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FDA 510(k)

POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG

K-Number: K102790 · 2010-11-29

ApplicantPerusahaan Getah Asas Sdn. Bhd.
Decision Date2010-11-29
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG is the device name listed in this FDA 510(k) record. The listed applicant is Perusahaan Getah Asas Sdn. Bhd.. It received FDA 510(k) clearance on 2010-11-29 under 510(k) number K102790. 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 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG?

POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG is a medical device that received FDA 510(k) clearance on 2010-11-29. The listed applicant is Perusahaan Getah Asas Sdn. Bhd.. The 510(k) number is K102790.

When did POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG receive FDA 510(k) clearance?

POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG received FDA 510(k) clearance on 2010-11-29, under 510(k) number K102790.

Who is the listed applicant for POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG?

The FDA 510(k) record lists Perusahaan Getah Asas Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG?

The FDA product code for POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG is LZC.

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Other records listing Perusahaan Getah Asas Sdn. Bhd. 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.

K042805POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILEK032374POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLOREDK031625POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLOREDK031768BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLOREDK031414POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABEK031591POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED

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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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