FDA 510(k)

PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)

K-Number: K973059 · 1997-11-07

Decision Date1997-11-07

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) is the device name listed in this FDA 510(k) record. The listed applicant is Sri Johani Sdn. Bhd.. It received FDA 510(k) clearance on 1997-11-07 under 510(k) number K973059. 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 PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)?

PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) is a medical device that received FDA 510(k) clearance on 1997-11-07. The listed applicant is Sri Johani Sdn. Bhd.. The 510(k) number is K973059.

When did PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) receive FDA 510(k) clearance?

PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) received FDA 510(k) clearance on 1997-11-07, under 510(k) number K973059.

Who is the listed applicant for PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)?

The FDA 510(k) record lists Sri Johani Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)?

The FDA product code for PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) is LZA.

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Other records listing Sri Johani Sdn. Bhd. as applicant

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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.