FDA 510(k) clearance · back to tracker

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)

Hartalega Sdn Bhd cleared K200897 on 2020-06-01, decision: substantially equivalent

K-number

K200897

Sponsor

Hartalega Sdn Bhd

Device

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)

Class

Class I

Decision

Substantially Equivalent

Decision date

2020-06-01

Product code

KGO

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4460

Official FDA record

Open K200897on accessdata.fda.gov →

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

openFDA JSON

Raw record →

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

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Drop K200897 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

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