FDA 510(k)

PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE

K-Number: K982885 · 1998-12-04

ApplicantShanghai Poseidon Plastic Products Co., Ltd.

Decision Date1998-12-04

Product CodeLYZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Poseidon Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 1998-12-04 under 510(k) number K982885. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE?

PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1998-12-04. The listed applicant is Shanghai Poseidon Plastic Products Co., Ltd.. The 510(k) number is K982885.

When did PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE receive FDA 510(k) clearance?

PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE received FDA 510(k) clearance on 1998-12-04, under 510(k) number K982885.

Who is the listed applicant for PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE?

The FDA 510(k) record lists Shanghai Poseidon Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE?

The FDA product code for PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE is LYZ.

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Other records listing Shanghai Poseidon Plastic Products Co., Ltd. as applicant

K001836NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE K001837NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE K001549MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)K001128NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE K992979SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW K964545POWDER FREE VINYL EXAMINATION GLOVE

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Related Devices (Code: LYZ)

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

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.