1、A-A-53562 65 m 777777q 0033364 3 m h C-8Y-/r A-A-5 3 56 2 30 June 1988 COMMERCIAL ITEM DESCRIPTION GLOVE, PATIENT EXAMINING AND TREATMENT (Plastic, Large Size, Sterile) The General Services Administration has authorized the use of this commercial item description. This commercial item description co
2、vers a sterile, disposable, impermeable, light-weight seamless plastic glove of one size which fits either hand. Glove shall be suitable for medical use in examinations, diagnostic and therapeutic procedures by physicians, nurses and paramedical personnel in clinie-and nursing-unit care. Salient ch?
3、.racterisEics: . -. Material?. The glove shall be fabricated from virgin, translucent polyvinyl chloride. Dusting powder. Should dusting powder be used,. the gloves shall be uniformly prepowdered on the interior only with a minimum of Absorbabie Dusting Powder, USP. - Style and design. The patient e
4、xamining glove shall be constructed in one piece, free of seams and welts, and shall have a smooth finish. Shall be a five-fingered glove suitable for use on either hand. A smallcontinuous bead shall be formed on the glove circumference at the cuff end to prevent tearing. The glove shall be supplied
5、 in a folded inner wrapper which in tyrn shall be enclosed in an outer wrapper as specified below. The glove shall be placed flat, prior to folding the inner wrapper over glove, with the cuff folded over for 1-1/2 to 3-1/2 inches. The- inner wrapper shall be of sufficient size to permit such flat pl
6、acement of the glove and shall completely cover and separate glove from outer wrapper. The inner wrapper shall be folded in such a manner as to permit easy removal of the glove. Inner wrapper shall have the “CUFF END“ and “THUMB“ clearly marked on it. The glove shall not slide in the package or adhe
7、re to the inner wrapper while in storage. AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. THIS DOCUMENT CONTAINS 7 PAGES. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53562 b5 9999974 0031Eb5
8、 5 A-A-5 3 5 6 2 Dimensions. The glove shall have the dimensions (in inches) as indicated in Table 1. Sterility. pyrogens in accordance with the USP. minimum sterility assurance level of i x 10-4. The glove shall be sterile and free from The glove shall have a Freedom fmm pinholes. The glove shall b
9、e supplied free of pinholes. The sloyshall not leak when filled with 400 ml * of water and suipended from the cuff end for 5 minutes, Finish. The glove shall have a visually dull but smooth-to- the-touch exterior, and visually glossy an smooth-to-the- touch interior surface. The glove shall be free
10、from holes, visible ingrained particles, tackiness, bloom, strings, bleedingr and other imperfections, Low temprature flexibility. -200F after being held at that temperature for 1/2 hour and then flexed with a wooden rod. The glove shall not crack at High temperature exposure. exposure in a mechanic
11、al convection oven at 1650F or 72 hours without evidence of tackiness, plasticizer exudation, OE other deterioration. It shall be examined after it is at a nominal 750F. The glove shall withstand Instructions. Each envelope shall be labeled with instructions for withdrawing and donning the glove wit
12、hout compromising its sterility. Workmanship. Workmanship shall be first class throughout. Gloves shall be free from defects which detract from their appearance OK may impair their serviceability. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A
13、-53 5 6 2 TABLE I. L Characteristic Dimensions I Overall lenqth 10 + 1, -1/4 Flat width it wrist Flat width at palm at base of thumb Length of thumb Length of little finger Length of middle finger Length of index and ring fingers Flat width of thumb at base Flat width of thumb 3/4 inch from tip Flat
14、 width of base of index, middle Same as line above, 3/4 inch from tips Flat width of base of little finger Same as line above, 3/4 inch from tip Thickness at finger tips Thickness at remainder of glove (except and ring fingers for area adjacent to cuff edge) 4-1/4 + 1/2, -1/4 4-1/4 + 1/4 2-3/8 T 1/4
15、 2-1/4 T 1/8 2-7/8 + 3/8 1-1/2,-+ 1/8 l-Z/4, T 1/4, -3/l 3 + i/4 1-1/4 + 1/8 1-1/8 T 1/8 1-1/8 T 1/8 1-1/8 T 1/8 0.0025-to 0.0045 0.005 to 0.008 Outer wrapper (envelope) . The outer wrapper (envelope) shall completely enclose the inner wrapper and glove, and shall be capable of maintaining sterility
16、 of the glove. - Outer wrapper shall be so designed as to permit ready dispensing of the contents by sterile techniques. Closure of the outer wrapper shall be accomplished by heat or cold sealing. The outer wrapper shall be a sealed, peel-back outer wrapper. The peeled back design shall include two
17、free tabs along the top edge of the wrapper. The tabs shall be capable of being readily peeled back along the sealed edges to expose the inner wrapper-. Physical requirements. The gloves shall comply with the physical requirements contained in Table II. Tests for physical requirements shall be condu
18、cted in accordance with ASTM D882. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-535bZ b5 M 499997ri 00311b7 4 M A-A-5 3 5 62 TABLE II. Physical Requirements. strength - pounds per square inch(average).L500 min.: strength - pounds per square
19、inch(sing1e glove)l300 min. elongation at break.280 min. strength - pounds per inch of width .5 min. * The tensile strength shall be run on a minimum of 30 - Unit. Package (PG). One package containing 100 Individually packaged sterile gloves, as specified, constitutes one unit. gloves and represents
20、 an average value. Quality Assurance Provisions. the contract: or purchase order, the contractor is responsible for the pegformance of all inspection requirements as specified herein. Except as otherwise specified in the contract or purchase order, the contractor may use his own or any facilities su
21、itable or the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set foxth in the specification where such inspections are deemed necessary to assure supplies and services conform to p
22、rescribed requirements. monsibility for inspection. Unless otherwise specified in Records. Records of examinations and tests performed by or foi: the contractor chal1 be maintained by the contractor and made available to the Government upon the Governments request, at any time, or from time to time,
23、 during the performance of the contract and for a period o three years after delivery of the supplies to which such records relate. Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investigation without the use of special laboratory appliances or pro
24、cedures) and testing (determination by technical means of physical and chemicai properties) of the item. specification requirements. Where feasible, the same sample shall be used for the determination of two or more test characteristics. Tests. Tests shall be conducted to determine compliance with 4
25、 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53562 65 777777LI 0033368 O M A-A-5 3 562 Sampling for examination. Sampling for examination shall be in accordance with MIL-STD-105 with and AQL of 1.0 (percent defective) and an Inspection Level
26、of S-3. The unit of product for examination purposes shall be one glove. Sampling for testing. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified herein. The unit of product for test purposes shall be one glove. AQL shall be 2.5 with an inspection level of S-3. Def
27、ects Tears, large holes. Blisters. Imbedded grit-like particles. Ingrained grit-like particles clearly Excessively thin spots (under 0.0025 Tackiness. No inner wrapper included. CUFF END not identified on inner wrapper. Glove adhering to inner wrapper. Gloves not having a small continuous bead locat
28、ed upon the cuff end. Gloves powdered on exterior. Foreign matter present. Bloom, bleeding, strings, and other Fingertips thickness over 0.0045 inch. Palm thickness over 0.008 inch. noticeable without distending the glove. inch) . imperfections. Contractor certification. The contractor shall certify
29、 that the product offered meets the salient characteristics of this desciiption and conforms to the producers own drawings, specifications, standards, and quality assurance practices. The Government reserves the right to require proof of such conformance prior to first delivery and thereafter as may
30、 be otherwise provided for under the provisions of the contract. 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5 3 5 6 2 Regulatory requirements, by this document has been detexmined by the U.S. Food and Drug Administration to be under its ju
31、risdiction, the offeror/contractor shall comply, and be responsibe for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and xegulations promulgated thereunder. In addition, the offeroc/contractor shall comply, and be responsibl
32、e for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations. use recovered material in accordance with Public Law 94-580 to the maximum extent practical. Federal Food, Drug and Cosmetic Act. If the pr
33、oduct covered Recovered materials. The offeror/contractor is encouraged to Preservation, packaging, packing, labeling, and marking. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents thereof under norma
34、l shipping conditions, handling, etc., involving shipment from the supply source to the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carriers rules and xegulations. Intermediate and exterior package quantities and labeling and marking shall be as speci
35、fied in the contract and/or ordel: . NOTE: The following National Stock Number is covered by this document: NSN 6515-00-226-7692 - ITEM IDENTIFICATION GLOVE, PATIENT EXAMINING AND TREATMENT, Plastic, Large Size, Disposable, Sterile, 100s Ordering data (Intermsdiate/exterior packaging quantities and
36、labeling and marking must be specified in the contract and/or ordex) MILITARY INTERESTS: Preparing Activity: Custodians : DoD-MB Army - MD NVY - MS Air Force - 03 Agent: DLA-DM Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5 3 5 6 2 CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS Project No. 6515-4215 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-
