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FDA 510(k)

NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE

K-Number: K992177 · 1999-07-29

ApplicantPt. Berlian Glovindo
Decision Date1999-07-29
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Berlian Glovindo. It received FDA 510(k) clearance on 1999-07-29 under 510(k) number K992177. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE?

NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE is a medical device that received FDA 510(k) clearance on 1999-07-29. The listed applicant is Pt. Berlian Glovindo. The 510(k) number is K992177.

When did NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE receive FDA 510(k) clearance?

NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE received FDA 510(k) clearance on 1999-07-29, under 510(k) number K992177.

Who is the listed applicant for NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE?

The FDA 510(k) record lists Pt. Berlian Glovindo as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE?

The FDA product code for NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE is LZA.

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Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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