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FDA 510(k)

PROTEX (PATIENT EXAMINATION GLOVES)

K-Number: K892102 · 1989-05-31

ApplicantHon Shan Development , Ltd.
Decision Date1989-05-31
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROTEX (PATIENT EXAMINATION GLOVES) is the device name listed in this FDA 510(k) record. The listed applicant is Hon Shan Development , Ltd.. It received FDA 510(k) clearance on 1989-05-31 under 510(k) number K892102. 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 PROTEX (PATIENT EXAMINATION GLOVES)?

PROTEX (PATIENT EXAMINATION GLOVES) is a medical device that received FDA 510(k) clearance on 1989-05-31. The listed applicant is Hon Shan Development , Ltd.. The 510(k) number is K892102.

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

PROTEX (PATIENT EXAMINATION GLOVES) received FDA 510(k) clearance on 1989-05-31, under 510(k) number K892102.

Who is the listed applicant for PROTEX (PATIENT EXAMINATION GLOVES)?

The FDA 510(k) record lists Hon Shan Development , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTEX (PATIENT EXAMINATION GLOVES)?

The FDA product code for PROTEX (PATIENT EXAMINATION GLOVES) is LYY.

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Official Source

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