510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K891965Substantially Equivalent

Sofcare Patient Examination Gloves (Latex)

P. T. Tata Rubberindo Industries, Kav 22, Jakarta, ID / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891965 is the FDA 510(k) clearance record for SOFCARE PATIENT EXAMINATION GLOVES (LATEX), a class I device, cleared for P. T. Tata Rubberindo Industries on under FDA product code LYY (Latex Patient Examination Glove). FDA's definition for product code LYY reads: "A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against...". FDA records list 2 510(k) clearances for P. T. Tata Rubberindo Industries, from to . As of , FDA records show no recalls naming K891965.

Clearance record

Decision date
Received
(155 days to decision)
Product code
LYY Latex Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
P. T. Tata Rubberindo Industries 12th Floor, Wisma Argo Manunggal, Kav 22, Jakarta, ID
Third party review
No

Clearances, product code LYY

Trailing 12 months

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

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