FDA-Device2018-06-06Class II
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
WRP Asia Pacific Sdn Bhd
Hazard
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.
Sold states
Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX.
Affected count
201,000 pairs
Manufactured in
Lot 1, Perusahaan Bandar Baru, Jalan 3, Sepang, N/A, Malaysia
Products
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2036-2018Don't want to check this manually?
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