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FDA 510(k)

HANDCARE PATIENT EXAMINATION GLOVES

K-Number: K892948 · 1989-08-21

ApplicantSouth Pacific Chemical Industries Sdn Bhd
Decision Date1989-08-21
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HANDCARE PATIENT EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is South Pacific Chemical Industries Sdn Bhd. It received FDA 510(k) clearance on 1989-08-21 under 510(k) number K892948. 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 HANDCARE PATIENT EXAMINATION GLOVES?

HANDCARE PATIENT EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is South Pacific Chemical Industries Sdn Bhd. The 510(k) number is K892948.

When did HANDCARE PATIENT EXAMINATION GLOVES receive FDA 510(k) clearance?

HANDCARE PATIENT EXAMINATION GLOVES received FDA 510(k) clearance on 1989-08-21, under 510(k) number K892948.

Who is the listed applicant for HANDCARE PATIENT EXAMINATION GLOVES?

The FDA 510(k) record lists South Pacific Chemical Industries Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANDCARE PATIENT EXAMINATION GLOVES?

The FDA product code for HANDCARE PATIENT EXAMINATION GLOVES is LYY.

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Related Devices (Code: LYY)

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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