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FDA 510(k)

ABSOGEL CHEMOTHERAPHY GLOVES

K-Number: K990677 · 1999-11-01

ApplicantAmpri Rubberware Industries Sdn Bhd
Decision Date1999-11-01
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ABSOGEL CHEMOTHERAPHY GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Ampri Rubberware Industries Sdn Bhd. It received FDA 510(k) clearance on 1999-11-01 under 510(k) number K990677. 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 ABSOGEL CHEMOTHERAPHY GLOVES?

ABSOGEL CHEMOTHERAPHY GLOVES is a medical device that received FDA 510(k) clearance on 1999-11-01. The listed applicant is Ampri Rubberware Industries Sdn Bhd. The 510(k) number is K990677.

When did ABSOGEL CHEMOTHERAPHY GLOVES receive FDA 510(k) clearance?

ABSOGEL CHEMOTHERAPHY GLOVES received FDA 510(k) clearance on 1999-11-01, under 510(k) number K990677.

Who is the listed applicant for ABSOGEL CHEMOTHERAPHY GLOVES?

The FDA 510(k) record lists Ampri Rubberware Industries Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABSOGEL CHEMOTHERAPHY GLOVES?

The FDA product code for ABSOGEL CHEMOTHERAPHY GLOVES is LZC.

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Other records listing Ampri Rubberware Industries 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.

K990812POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTAK954002AMPRIK952833AMPRIK945948ABSOGEL STERILE POWDER-FREE SURGICAL GLOVESK946056ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE)K892176CORRECT TOUCH SURGEONS GLOVES

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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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