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FDA 510(k)

POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)

K-Number: K120968 · 2012-09-19

ApplicantTangshan Zhonghong Pulin Plastic Co.,Ltd
Decision Date2012-09-19
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) is the device name listed in this FDA 510(k) record. The listed applicant is Tangshan Zhonghong Pulin Plastic Co.,Ltd. It received FDA 510(k) clearance on 2012-09-19 under 510(k) number K120968. 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 POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)?

POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) is a medical device that received FDA 510(k) clearance on 2012-09-19. The listed applicant is Tangshan Zhonghong Pulin Plastic Co.,Ltd. The 510(k) number is K120968.

When did POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) receive FDA 510(k) clearance?

POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) received FDA 510(k) clearance on 2012-09-19, under 510(k) number K120968.

Who is the listed applicant for POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)?

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

What is the FDA product code for POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)?

The FDA product code for POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) is LYZ.

Related Clinical Trials

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.

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Other records listing Tangshan Zhonghong Pulin Plastic Co.,Ltd 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.

K120970NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)

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

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

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