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FDA 510(k)

SHIELD BRAND (PATIENT EXAMINATION GLOVE)

K-Number: K891102 · 1989-07-14

ApplicantPoly Shield Industries (Malaysia) Sdn. Bhd.
Decision Date1989-07-14
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHIELD BRAND (PATIENT EXAMINATION GLOVE) is the device name listed in this FDA 510(k) record. The listed applicant is Poly Shield Industries (Malaysia) Sdn. Bhd.. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K891102. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIELD BRAND (PATIENT EXAMINATION GLOVE)?

SHIELD BRAND (PATIENT EXAMINATION GLOVE) is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Poly Shield Industries (Malaysia) Sdn. Bhd.. The 510(k) number is K891102.

When did SHIELD BRAND (PATIENT EXAMINATION GLOVE) receive FDA 510(k) clearance?

SHIELD BRAND (PATIENT EXAMINATION GLOVE) received FDA 510(k) clearance on 1989-07-14, under 510(k) number K891102.

Who is the listed applicant for SHIELD BRAND (PATIENT EXAMINATION GLOVE)?

The FDA 510(k) record lists Poly Shield Industries (Malaysia) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHIELD BRAND (PATIENT EXAMINATION GLOVE)?

The FDA product code for SHIELD BRAND (PATIENT EXAMINATION GLOVE) is LYY.

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Related Devices (Code: LYY)

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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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