FDA 510(k)

PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS)

K-Number: K892153 · 1989-07-14

Decision Date1989-07-14

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS) is the device name listed in this FDA 510(k) record. The listed applicant is Sinochem (Usa), Inc.. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K892153. 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 PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS)?

PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS) is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Sinochem (Usa), Inc.. The 510(k) number is K892153.

When did PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS) receive FDA 510(k) clearance?

PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS) received FDA 510(k) clearance on 1989-07-14, under 510(k) number K892153.

Who is the listed applicant for PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS)?

The FDA 510(k) record lists Sinochem (Usa), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS)?

The FDA product code for PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS) is LYY.

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Other records listing Sinochem (Usa), Inc. as applicant

K900980LATEX EXAMINATION GLOVES K901398LATEX SURGEON GLOVES K900352LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES)K893882LATEX EXAMINATION GLOVES K893694LATEX EXAM GLOVES(MFG: SHANG HAI RONGTONG LATEX)K892155PATIENT EXAM GLOVES (MFG. HUBEI TIANMEN LATEX)

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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.