DOD A-A-54791-1993 GLOVES SURGEONS- LATEX RUBBER PRE-POWDERED DISPOSABLE STERILE《消毒可任意试用粉末胶乳橡胶外科医生手套》.pdf
《DOD A-A-54791-1993 GLOVES SURGEONS- LATEX RUBBER PRE-POWDERED DISPOSABLE STERILE《消毒可任意试用粉末胶乳橡胶外科医生手套》.pdf》由会员分享,可在线阅读,更多相关《DOD A-A-54791-1993 GLOVES SURGEONS- LATEX RUBBER PRE-POWDERED DISPOSABLE STERILE《消毒可任意试用粉末胶乳橡胶外科医生手套》.pdf(6页珍藏版)》请在麦多课文档分享上搜索。
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
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