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FDA 510(k)

PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)

K-Number: K101436 · 2010-11-17

ApplicantShen Wei (Usa), Inc.
Decision Date2010-11-17
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei (Usa), Inc.. It received FDA 510(k) clearance on 2010-11-17 under 510(k) number K101436. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)?

PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) is a medical device that received FDA 510(k) clearance on 2010-11-17. The listed applicant is Shen Wei (Usa), Inc.. The 510(k) number is K101436.

When did PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) receive FDA 510(k) clearance?

PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) received FDA 510(k) clearance on 2010-11-17, under 510(k) number K101436.

Who is the listed applicant for PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)?

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

What is the FDA product code for PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)?

The FDA product code for PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) is LZC.

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Other records listing Shen Wei (Usa), Inc. as applicant

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Related Devices (Code: LZC)

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.

K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealthK243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn BhdK220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.

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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