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FDA 510(k)

B-CARE POWDERED LATEX EXAMINATION GLOVES

K-Number: K052845 · 2005-12-16

ApplicantB-Care Industries Co., Ltd.
Decision Date2005-12-16
Product CodeOPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

B-CARE POWDERED LATEX EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is B-Care Industries Co., Ltd.. It received FDA 510(k) clearance on 2005-12-16 under 510(k) number K052845. The device is classified under product code OPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B-CARE POWDERED LATEX EXAMINATION GLOVES?

B-CARE POWDERED LATEX EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2005-12-16. The listed applicant is B-Care Industries Co., Ltd.. The 510(k) number is K052845.

When did B-CARE POWDERED LATEX EXAMINATION GLOVES receive FDA 510(k) clearance?

B-CARE POWDERED LATEX EXAMINATION GLOVES received FDA 510(k) clearance on 2005-12-16, under 510(k) number K052845.

Who is the listed applicant for B-CARE POWDERED LATEX EXAMINATION GLOVES?

The FDA 510(k) record lists B-Care Industries Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-CARE POWDERED LATEX EXAMINATION GLOVES?

The FDA product code for B-CARE POWDERED LATEX EXAMINATION GLOVES is OPE.

Related Clinical Trials

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Other records listing B-Care Industries Co., Ltd. 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.

K051404B-CARE POWDER FREE LATEX EXAMINATION GLOVES

Related Devices (Code: OPE)

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.

K944778LATEX EXAMINATION GLOVESPt. Haloni JaneK895642LATEX PATIENT EXAMINATION GLOVESSiam Sempermed Corp., 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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