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FDA 510(k)

ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW

K-Number: K012339 · 2001-10-16

ApplicantShanghai Antares Industries, Inc.
Decision Date2001-10-16
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Antares Industries, Inc.. It received FDA 510(k) clearance on 2001-10-16 under 510(k) number K012339. 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 ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW?

ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW is a medical device that received FDA 510(k) clearance on 2001-10-16. The listed applicant is Shanghai Antares Industries, Inc.. The 510(k) number is K012339.

When did ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW receive FDA 510(k) clearance?

ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW received FDA 510(k) clearance on 2001-10-16, under 510(k) number K012339.

Who is the listed applicant for ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW?

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

What is the FDA product code for ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW?

The FDA product code for ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW is LYZ.

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Other records listing Shanghai Antares 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.

K052612DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLORK021853DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FREE WITH VITAMIN EK020943STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREEK012499ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVESK003321DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLORK000953DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

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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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