FDA 510(k)

SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES

K-Number: K971666 · 1997-07-03

ApplicantSj Medical Products (M) Sdn Bhd

Decision Date1997-07-03

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Sj Medical Products (M) Sdn Bhd. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K971666. 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 SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES?

SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Sj Medical Products (M) Sdn Bhd. The 510(k) number is K971666.

When did SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES receive FDA 510(k) clearance?

SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES received FDA 510(k) clearance on 1997-07-03, under 510(k) number K971666.

Who is the listed applicant for SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES?

The FDA 510(k) record lists Sj Medical Products (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES?

The FDA product code for SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES is LZA.

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Other records listing Sj Medical Products (M) Sdn Bhd as applicant

K971665SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES K971403SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE K941754POWDER FREE LATEX EXMINATION GLOVES K932332PATIENT EXAMINATION GLOVE - POWDERED

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.