FDA 510(k)

POWDER FREE SYNTHETIC EXAMINATION GLOVES

K-Number: K971356 · 1997-09-05

ApplicantArista Latindo Industrial Ltd. P.T

Decision Date1997-09-05

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER FREE SYNTHETIC EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Arista Latindo Industrial Ltd. P.T. It received FDA 510(k) clearance on 1997-09-05 under 510(k) number K971356. 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 POWDER FREE SYNTHETIC EXAMINATION GLOVES?

POWDER FREE SYNTHETIC EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1997-09-05. The listed applicant is Arista Latindo Industrial Ltd. P.T. The 510(k) number is K971356.

When did POWDER FREE SYNTHETIC EXAMINATION GLOVES receive FDA 510(k) clearance?

POWDER FREE SYNTHETIC EXAMINATION GLOVES received FDA 510(k) clearance on 1997-09-05, under 510(k) number K971356.

Who is the listed applicant for POWDER FREE SYNTHETIC EXAMINATION GLOVES?

The FDA 510(k) record lists Arista Latindo Industrial Ltd. P.T as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER FREE SYNTHETIC EXAMINATION GLOVES?

The FDA product code for POWDER FREE SYNTHETIC EXAMINATION GLOVES is LZA.

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Related Devices (Code: LZA)

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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.