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Glove tested according to AQL standard

What is Acceptable Quality Level (AQL) and why it matters?

Acceptable Quality Level (AQL) is an international industry standard sampling process for evaluating the quality of a finished glove product. AQL measures quality by determining the highest number of defects accepted in a random selection of a glove product batch. The lower the AQL, the better the quality and less likelihood of defects.

AQL is a pass/fail where a predetermined sample size of a manufactured lot is assessed following the sampling plan and protocols established by the various international standards. More stringent standards can also be set by manufacturers to ensure stricter and higher quality is delivered to the customer. The sampling plan is an inspection procedure of a sample size (which are gloves that are randomly selected from a batch of gloves) that is used to determine acceptance or rejection criteria from an inspection batch or lot. The sample size to be tested is set by:

  • The lot or batch size
  • The inspection level - determined by region as reflected in Table 1
  • AQL level specified in standards for the market or determined by individual manufacturers

Surgical Gloves Standards Inspection Level AQL

AS/NZS 4179:20141
Applicable to Australia/New Zealand

G1 1.0

ASTM 3577:20092
Applicable to US & Canada

G1 1.5

EN 455 Part 1:20003
Applicable to the European Union

G1 1.5

ISO 10282:20144
Adopted by the rest of the World

G1 1.5

JIS T9107:20055
Applicable to Japan

G1 1.5


Table 1: Surgical Gloves Standards


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Sources:
1. AS/NZS 4179:2014 Single-use sterile rubber surgical gloves http://infostore.saiglobal.com/store/Details.aspx?ProductID=1742680 Accessed 4-12-15
2. ASTM 3577:2009 Standard Specification for Rubber Surgical Gloves http://www.astm.org/Standards/D3577.html Accessed 4-12-15
3. EN 455 Part 1: 2000 Medical Gloves for single use http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/me dical-devices/index_en.htm Accessed 4-12-15
4. ISO 10282:2014 Single-use sterile rubber surgical gloves http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=63706 Accessed 4-12-15
5. JIS T 9107:2005 Single-use Sterile Surgical Rubber Gloves http://infostore.saiglobal.com/store/Details.aspx?ProductID=800132 Accessed 4-12-15

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