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FDA 510(k)

VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE

K-Number: K040916 · 2005-05-04

ApplicantVitalcare Group, Inc.
Decision Date2005-05-04
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Vitalcare Group, Inc.. It received FDA 510(k) clearance on 2005-05-04 under 510(k) number K040916. 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 VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE?

VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 2005-05-04. The listed applicant is Vitalcare Group, Inc.. The 510(k) number is K040916.

When did VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE receive FDA 510(k) clearance?

VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE received FDA 510(k) clearance on 2005-05-04, under 510(k) number K040916.

Who is the listed applicant for VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE?

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

What is the FDA product code for VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE?

The FDA product code for VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE is LYZ.

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Other records listing Vitalcare Group, 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.

K060109OMI RETRACTABLE SAFETY SYRINGEK050906VITALCARE I.V. ADMINISTRATION SETK031748VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGESK992289VINYL POWDERED EXAM GLOVE / CAT.# 15-020K983016GAUZE, SPONGES, CAT # 11-003K983716VITALCARE DISPOSABLE VAGINAL SPECULUM

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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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