510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K052845Substantially Equivalent

B-Care Powdered Latex Examination Gloves

B-Care Industries Co., Ltd., Littleton CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K052845 is the FDA 510(k) clearance record for B-CARE POWDERED LATEX EXAMINATION GLOVES, cleared for B-Care Industries Co., Ltd. on under FDA product code OPE. FDA records list 2 510(k) clearances for B-Care Industries Co., Ltd., from to . As of , FDA records show no recalls naming K052845.

Clearance record

Decision date
Received
(70 days to decision)
Product code
OPE
Review panel
General Hospital
Applicant
B-Care Industries Co., Ltd. 13 Red Fox Ln., Littleton CO
510(k) summary
Statement
Third party review
No

Clearances, product code OPE

Trailing 12 months

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

FDA records show no clearances under product code OPE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OPE, 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