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FDA 510(k)

PRE-POWDERED STERILE VINYL GLOVE, CLEAR

K-Number: K053521 · 2006-03-29

ApplicantShijiazhuang Hongxiang Plastics Products Co., Ltd.
Decision Date2006-03-29
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRE-POWDERED STERILE VINYL GLOVE, CLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Shijiazhuang Hongxiang Plastics Products Co., Ltd.. It received FDA 510(k) clearance on 2006-03-29 under 510(k) number K053521. 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 STERILE VINYL GLOVE, CLEAR?

PRE-POWDERED STERILE VINYL GLOVE, CLEAR is a medical device that received FDA 510(k) clearance on 2006-03-29. The listed applicant is Shijiazhuang Hongxiang Plastics Products Co., Ltd.. The 510(k) number is K053521.

When did PRE-POWDERED STERILE VINYL GLOVE, CLEAR receive FDA 510(k) clearance?

PRE-POWDERED STERILE VINYL GLOVE, CLEAR received FDA 510(k) clearance on 2006-03-29, under 510(k) number K053521.

Who is the listed applicant for PRE-POWDERED STERILE VINYL GLOVE, CLEAR?

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

What is the FDA product code for PRE-POWDERED STERILE VINYL GLOVE, CLEAR?

The FDA product code for PRE-POWDERED STERILE VINYL GLOVE, CLEAR is LYZ.

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Other records listing Shijiazhuang Hongxiang Plastics Products 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.

K053523POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW)K042247SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREEK001863SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVESK001861SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVESK001834SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVESK001862SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES

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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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