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FDA 510(k)

LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES)

K-Number: K900352 · 1990-03-27

ApplicantSinochem (Usa), Inc.
Decision Date1990-03-27
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES) 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 1990-03-27 under 510(k) number K900352. 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 LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES)?

LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES) is a medical device that received FDA 510(k) clearance on 1990-03-27. The listed applicant is Sinochem (Usa), Inc.. The 510(k) number is K900352.

When did LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES) receive FDA 510(k) clearance?

LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES) received FDA 510(k) clearance on 1990-03-27, under 510(k) number K900352.

Who is the listed applicant for LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES)?

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 LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES)?

The FDA product code for LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES) is LYY.

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

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.

K900980LATEX EXAMINATION GLOVESK901398LATEX SURGEON GLOVESK893882LATEX EXAMINATION GLOVESK893694LATEX EXAM GLOVES(MFG: SHANG HAI RONGTONG LATEX)K892151PATIENT EXAM GLOVES (MFG. GUILIN LATEX FACTORY)K892153PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS)

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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.

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company LimitedK230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn BhdK223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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