FDA 510(k) clearance · back to tracker

POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)

Hartalega Sdn Bhd cleared K170152 on 2017-05-05, decision: substantially equivalent

K-number

K170152

Sponsor

Hartalega Sdn Bhd

Device

POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)

Class

Class I

Decision

Substantially Equivalent

Decision date

2017-05-05

Product code

KGO

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4460

Official FDA record

Open K170152on 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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Raw record →

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.