Cleared Traditional

K030994 - NON-STERILE ORANGE COLORED POWDERED LAT...

K030994 is the FDA 510(k) clearance for NON-STERILE ORANGE COLORED POWDERED LAT... by Sgmp Co., Ltd.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K030994 · Sgmp Co., Ltd. · General Hospital
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Jun 2003
Decision
76d
Days
Class 1
Risk

K030994 is an FDA 510(k) clearance for the NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & W.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sgmp Co., Ltd. (Sparks, US). The FDA issued a Cleared decision on June 12, 2003 after a review of 76 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 K030994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2003
Decision Date June 12, 2003
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
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 K030994.
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE
K031414 · Perusahaan Getah Asas Sdn. Bhd. · Jun 2003
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K031021 · Perusahaan Getah Asas Sdn. Bhd. · Jun 2003
NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR/APPLE/PEPPERMINT SCENTS
K030993 · Sgmp Co., Ltd. · Jun 2003
ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM
K030331 · Perusahaan Getah Asas Sdn. Bhd. · Mar 2003
LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM
K030333 · Perusahaan Getah Asas Sdn. Bhd. · Mar 2003
POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM
K030157 · Wrp Asia Pacific Sdn. Bhd. · Feb 2003