Cleared Traditional

K070038 - POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW

K070038 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION GLOVE, manufactured by Super Safe Plastic Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K070038 · Super Safe Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
79d
Days
Class 1
Risk

K070038 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Super Safe Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on March 23, 2007 after a review of 79 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. 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.

FDA 510(k) Submission Details - K070038

510(k) Number K070038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date March 23, 2007
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 129d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

LYZ Device Classification - Class 1, General Controls

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LYZ Vinyl Patient Examination Glove

All 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K070038.
POWDER-FREE VINYL EXAMINATION GLOVES
K071022 · Glormed Colombia S.A. · Jul 2007
PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES
K070519 · Zhang Jia Gang Huayuan Plastic Co. , Ltd. · Apr 2007
POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
K070041 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · Mar 2007
POWDERED (WHITE) VINYL PATIENT EXAMINATION
K070027 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · Mar 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
K070188 · Hong DI Plastic Products Co., Ltd. · Mar 2007
POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K070026 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · Mar 2007
K070038 · POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
Download PDF FDA Summary Super Safe Plastic Pr…