1、1 METRIC I A-A-54 7 9 1 30 January 1993 COMMERCIAL ITEM DESCRIPTION GLOVES, SURGEONS, Latex Rubber, Pre-Powdered, Disposable, Sterile The General Services Administration has authorized the use of this Commercial Item Description. This Commercial Item Description covers sterile, disposable, latex rub
2、ber surgeons gloves suitable for use in surgical procedures. Salient Characteristics: General. “Gloves“, as used herein, shall refer to all surgeons gloves covered by the scope of this document. Gloves shall be hand-specific: one glove shall fit a users right hand; the other shall fit a users left h
3、and. Glove sizes shall be limited to the following: 6, 6-1/2, 7, 7-i/2, 8, and 8-1/2. Dimensions. Gloves shall comply with the dimensional requirements specified in ASTM D3577. The dimensions of glove samples shall be inspected in accordance with ASTM D3577. Material. Gloves shall be made of latex r
4、ubber. This material shall comply with the requirements for one of the three types of latex rubber defined in ASTM D1076. Material samples shall be cut from finished gloves and subjected to all inspections specified by ASTM D1076. Performance. Gloves shall be leakproof. Sample glove pairs shall be i
5、nspected for leaks in accordance with ASTM D5151-92. Physical Properties. Gloves shall comply with the Type I physical property requirements specified in ASTM D3577. The physical properties of glove samples shall be inspected in accordance with ASTM D3577. AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A:
6、 Approved for public release; distribution is unlimited. Licensed by Information Handling ServicesA-A-5q791 999997ir 01217331 bOO A-A-5 47 9 1 Finish. Gloves shall have a smooth, uniform finish. Gloves shall be pre-powdered with a USP-grade absorbable dusting powder. Gloves shall not be powdered wit
7、h talcum powder. Glove samples shall be inspected for finish. Glove powder samples shall be inspected for compliance with USP requirements (See Note 1). Markinq. Glove size shall be legibly and permanently marked on the exterior of the glove cuff. Glove samples shall be inspected for size markings.
8、Workmanship. Gloves shall be free from blooming, blisters, fish-eyes, frosting, shorts, wrinkles, foreign matter, visible holes, missing fingers, missing thumbs, fingers that are fused together, thumbs that are fused together, and any other defects that detract from their appearance or impair their
9、serviceability. The definitions of the first seven defect terms shall be as specified in ASTM D883. Glove samples shall be inspected for workmanship. Sterility. Gloves shall be sterile. The sterility assurance level shall be no less than Glove samples shall be inspected for sterility in accordance w
10、ith the latest edition of the USP. Sterile Packaqinq. Gloves shall be sterile-packed in pairs. one left-handed glove. A pair shall consist of one right-handed glove and Each pair of gloves in a unit package shall be sealed in a leak-proof, peel-open type packet designed to preserve the sterility of
11、its contents until opened or damaged (See “Sterility“), Packets shall be assembled in the following order: first, a glove pair shall be enclosed in a wrapper; second, the wrapped glove pair shall be sealed in an overwrap. Wrappers shall be made of paper or other suitable material. Overwraps shall be
12、 made of resin-impregnated paper, clear plastic, translucent plastic, or other suitable material. Overwraps shall be sealed by means of heat-sealing, cold-sealing, or any other method that produces a leak-proof seal. Sample packets shall be inspected for leaks in accordance with ASTM D3078. Sample p
13、ackets shall be examined for compliance with all other requirements listed above. Packets shall not generate loose fibers or other debris when opened. Sample packets shall be inspected for generation of fibers and debris. 2 Licensed by Information Handling ServicesA-A-54791 = 9999974 0121732 547 A-A
14、-54 7 9 1 Unit. Package (PG). One package containing 50 sterile-packed glove pairs as specified, constitutes one unit. The unit package shall be a top-opening and dispensing container. Oualitv Assurance Provisions. Responsibility - for Inspection. Unless otherwise specified in the contract or purcha
15、se order, the contractor is responsible for the performance 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 suitable for the performance of the inspection requirements specified here
16、in, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements. Records. Records of inspections performed by or
17、 for the contractor shall be maintained by the contractor and made available to the Government upon the Governments request, at any time, or from time to time, during the performance of the contract and for a period of three years after delivery of the supplies to which such records relate. Inspecti
18、on. Inspection, as used herein, shall be defined as the examination and testing of an item. Examination shall be defined as unaided visual, auditory, tactile, or olfactory investigation. Testing shall be defined as the use of laboratory equipment and procedures to determine various properties of an
19、item. Inspections shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the determination of two or more inspection characteristics. For inspection purposes, the unit of product shall be one pair of gloves. Samplinq for Inspecti
20、on. Sampling for inspection shall be conducted in accordance with MIL-STD-105. Nine samplings shall be performed - one for each salient characteristic specified herein. For each sampling, inspection level S-2 shall be used; the Acceptable Quality Level, (AQL) shall be 0.65 percent. 3 Licensed by Inf
21、ormation Handling ServicesA-A-54 7 9 1 Metric products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch-pound units, providing they fall within the tolerance specified using conversion tables contained in the latest revision of Feder
22、al Standard No. 376, and all other requirements of this document are met. If a product is manufactured to metric dimensions and those dimensions exceed the tolerances specified in the inch-pound units, a request should be made to the contracting officer to determine if the product is acceptable. The
23、 contracting officer has the option of accepting or rejecting the product. Contractor Certification. maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the producers own drawings, specifica
24、tions, standards, and quality assurance practices. The government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract. Requlatory Requirements. The contractor shall certify and Federal Fo
25、od, Druq, and Cosmetic Act. If the products covered by this document have been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federa
26、l Food, Drug, and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with all other applicable Federal, State, and local statutes, ordinances, and regulations. Recovere
27、d Materials. The offeror/contractor is encouraged to use recovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. 4 Licensed by Information Handling ServicesA-A-54731 M 3333374 O121734 31T A-A-54 7 9 1 Preservation, packaqinq, p ackinq, label
28、inq, and markinq. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc:, involving shipment from the supply source to the receiving activity, plus r
29、eshipment from receiving activity, and shall conform to applicable carriers rules and regulations. Intermediate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order. Orderinq Data. Intermediate/exterior package quantities, labeling, and marking
30、must be specified in the contract or order. Note 1: USP requirements for glove powder are given in the monograph entitled “Absorbable Dusting Powder“. Note 2: This document covers the following National Stock Numbers and their respective Item Identifications: NATIONAL STOCK NUMBERS ITEM IDENTIFICATI
31、ONS 6515-01-149-8839 GLOVES, SURGEONS, Latex Rubber, Size 6-1/2, Pre-Powered, Disposable, Sterile, 50 Pairs 6515-01-149-8840 GLOVES,SURGEONS, Latex Rubber, Size 7, Pre-Powdered, Disposable, Sterile, 50 Pairs 6515-01-149-8841 GLOVES, SURGEONS, Latex Rubber, Size 7-1/2, Pre-Powdered, Disposable, Steri
32、le, 50 Pairs 6515-01-149-8842 GLOVES, SURGEONS, Latex Rubber, Size 8, Pre-Powdered, Disposable, Sterile, 50 Pairs 6515-01-149-8843 GLOVES, SURGEONS, Latex Rubber, Size 8-1/2, Pre-Powdered, Disposable, Sterile, 50 Pairs 6515-01-151-1790 GLOVES, SURGEONS, Latex Rubber, Size 6, Pre-Powdered, Disposable
33、, Sterile, 50 Pairs 5 Licensed by Information Handling ServicesA-A-54791 D 9999974 0121735 25b D MILITARY INTERESTS: Custodians: Army - MD Navy - MS Air Force - 03 PREPARING ACTIVITY DoD - MB Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: I VA-OSS USPHS FDA-MPQAS Project No. 6515-5469 Location: c:wordkomadasl-glove 6 Licensed by Information Handling Services
