Cleared Traditional

K010947 - SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K010947 is an FDA 510(k) clearance for SNOW LOTUS POWDER FREE LATEX EXAMINATIO..., manufactured by Beijing Reagent Latex Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K010947 · Beijing Reagent Latex Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
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May 2001
Decision
57d
Days
Class 1
Risk

K010947 is an FDA 510(k) clearance for the SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELI.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Beijing Reagent Latex Products Co., Ltd. (Crofton, US). The FDA issued a Cleared decision on May 25, 2001 after a review of 57 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 Beijing Reagent Latex Products Co., Ltd. devices

FDA 510(k) Submission Details - K010947

510(k) Number K010947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2001
Decision Date May 25, 2001
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

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 808
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K010947.
STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED
K010856 · Brightway Holdings Sdn. Bhd. · Jun 2001
POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM
K011563 · U.O.P. Rubber Products Sdn Bhd · Jun 2001
X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K010961 · Ansell Healthcare Products, Inc. · May 2001
EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200
K011376 · Yty Industry (Manjung) Sdn Bhd · May 2001
UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K010881 · N.S. Uni-Gloves Sdn. Bhd. · May 2001
SKINGARD POLYCOAT GLOVE
K004018 · Top Quality Mfg., Inc. · May 2001