FDA 510(k) clearance · back to tracker

Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove

Hartalega NGC Sdn. Bhd. cleared K183389 on 2019-06-28, decision: substantially equivalent

K-number

K183389

Sponsor

Hartalega NGC Sdn. Bhd.

Device

Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove

Class

Class I

Decision

Substantially Equivalent

Decision date

2019-06-28

Product code

KGO

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4460

Official FDA record

Open K183389on 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.

Use this as a predicate

Drop K183389 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.