Cleared Traditional

B-CARE POWDERED LATEX EXAMINATION GLOVES (K052845) - FDA 510(k) Clearance

K052845 · B-Care Industries Co., Ltd. · General & Plastic Surgery device
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Dec 2005
Decision
70d
Days
-
Risk

K052845 is an FDA 510(k) clearance for the B-CARE POWDERED LATEX EXAMINATION GLOVES.

Submitted by B-Care Industries Co., Ltd. (Littleton, US). The FDA issued a Cleared decision on December 16, 2005 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K052845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2005
Decision Date December 16, 2005
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OPE
Device Class -