FDA 510(k) clearance · back to tracker

Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)

Careplus (M) Sdn Bhd cleared K211621 on 2021-10-06, decision: substantially equivalent

K-number

K211621

Sponsor

Careplus (M) Sdn Bhd

Device

Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)

Class

Class I

Decision

Substantially Equivalent

Decision date

2021-10-06

Product code

KGO

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4460

Official FDA record

Open K211621on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.