Cleared Traditional

K000867 - POWDER FREE LATEX EXAMINATION GLOVES

K000867 is the FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION GLOVES by Sgmp Co., Ltd.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K000867 · Sgmp Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
35d
Days
Class 1
Risk

K000867 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sgmp Co., Ltd. (Songkhla, TH). The FDA issued a Cleared decision on April 21, 2000 after a review of 35 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.

View all Sgmp Co., Ltd. devices

Submission Details

510(k) Number K000867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2000
Decision Date April 21, 2000
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 206
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K000867.
COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES
K001280 · Wrp Asia Pacific Sdn. Bhd. · May 2000
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS
K993760 · Hartalega Sdn Bhd · May 2000
POWDER FREE STERILE LATEX EXAMINATION GLOVES
K001141 · Allegiance Healthcare Corp. · May 2000
VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K000390 · Sgmp Co., Ltd. · Apr 2000
VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K000391 · Sgmp Co., Ltd. · Apr 2000
POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING
K000671 · Sgmp Co., Ltd. · Mar 2000