510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211758Substantially Equivalent

Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)

Hartalega NGC Sdn Bhd, Sepang, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K211758 is the FDA 510(k) clearance record for Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour), a class I device, cleared for Hartalega NGC Sdn. Bhd. on under FDA product code OPC (Powder-Free Polychloroprene Patient Examination Glove). FDA's definition for product code OPC reads: "A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier...". FDA records list 31 510(k) clearances for Hartalega NGC Sdn. Bhd., from to . As of , FDA records show no recalls naming K211758.

Clearance record

Decision date
Received
(57 days to decision)
Product code
OPC Powder-Free Polychloroprene Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Hartalega NGC Sdn. Bhd. # 1 Persiaran Tanjung, Sepang, MY
510(k) summary
Statement
Third party review
No

Clearances, product code OPC

Trailing 12 months

FDA records hold no clearances under product code OPC in the trailing twelve months.

FDA records show no clearances under product code OPC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OPC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260