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Recall Observatory FDA recall evidence

Device product

AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112

Z-2036-2018

May 07, 2018

Class II

Product summary

Firm
WRP Asia Pacific Sdn Bhd
Event
Event 79992
Status
Terminated
Classification
Class II
Quantity
201,000 pairs
Official record key
device-enforcement:Z-2036-2018

Official wording

Reason: Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in sensitization to latex and allergic reactions. Additional risks of powdered gloves include severe airway inflammation, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue.

Code information: Lot 705366565

Distribution pattern: Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in sensitization to latex and allergic reactions. Additional risks of powdered gloves include severe airway inflammation, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue.