FDA 510(k)

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)

Numéro K : K212532 · 2021-11-11

DemandeurCrdlight Optoelectronic Technology Co., Ltd.

Date de décision2021-11-11

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Crdlight Optoelectronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-11 under 510(k) number K212532. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)?

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-11-11. The listed applicant is Crdlight Optoelectronic Technology Co., Ltd.. The 510(k) number is K212532.

When did Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) receive FDA 510(k) clearance?

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) received FDA 510(k) clearance on 2021-11-11, under 510(k) number K212532.

Who is the listed applicant for Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)?

The FDA 510(k) record lists Crdlight Optoelectronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)?

The FDA product code for Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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