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FDA 510(k)

GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)

K-Number: K964321 · 1997-01-09

ApplicantShijiazhuang Hongray Plastic Products Co., Ltd.
Decision Date1997-01-09
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) is the device name listed in this FDA 510(k) record. The listed applicant is Shijiazhuang Hongray Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 1997-01-09 under 510(k) number K964321. 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 GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)?

GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) is a medical device that received FDA 510(k) clearance on 1997-01-09. The listed applicant is Shijiazhuang Hongray Plastic Products Co., Ltd.. The 510(k) number is K964321.

When did GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) receive FDA 510(k) clearance?

GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) received FDA 510(k) clearance on 1997-01-09, under 510(k) number K964321.

Who is the listed applicant for GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)?

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

What is the FDA product code for GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)?

The FDA product code for GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) is LYZ.

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Other records listing Shijiazhuang Hongray Plastic 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.

K994222SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLORK994206SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLORK992922SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLORK992860DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLORK982720H-RAY

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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