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FDA 510(k)

PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED

K-Number: K992100 · 1999-07-29

ApplicantShanghai Palomar Mountain Industries, Inc.
Decision Date1999-07-29
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Palomar Mountain Industries, Inc.. It received FDA 510(k) clearance on 1999-07-29 under 510(k) number K992100. 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 PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED?

PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED is a medical device that received FDA 510(k) clearance on 1999-07-29. The listed applicant is Shanghai Palomar Mountain Industries, Inc.. The 510(k) number is K992100.

When did PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED receive FDA 510(k) clearance?

PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED received FDA 510(k) clearance on 1999-07-29, under 510(k) number K992100.

Who is the listed applicant for PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED?

The FDA 510(k) record lists Shanghai Palomar Mountain Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED?

The FDA product code for PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED is LYZ.

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Other records listing Shanghai Palomar Mountain Industries, 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.

K031142DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLORK031072DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN EK030094DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLORK030148DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLORK023560ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDEREDK023343ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED

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Related Devices (Code: LYZ)

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.

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

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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