Cleared Traditional

K992417 - ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR

K992417 is an FDA 510(k) clearance for ROYAL SHIELD NON-STERILE POWDERED LATEX..., manufactured by Shield Gloves Manufacturer (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K992417 · Shield Gloves Manufacturer (M) Sdn Bhd · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
55d
Days
Class 1
Risk

K992417 is an FDA 510(k) clearance for the ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING .... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Shield Gloves Manufacturer (M) Sdn Bhd (Crofton, US). The FDA issued a Cleared decision on September 13, 1999 after a review of 55 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 - K992417

510(k) Number K992417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1999
Decision Date September 13, 1999
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 1238
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K992417.
DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
K992128 · Dash Medical Gloves Sdn Bhd · Sep 1999
QUALATEX POWDERED LATEX EXAMINATION GLOVES
K992557 · Tan Sin Lian Industries Sdn. Bhd. · Sep 1999
HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE
K992730 · Hwa Teh Industrial Sdn. Bhd. · Sep 1999
ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI
K992418 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1999
ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR
K992419 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1999
CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)
K992358 · Biopro (M) Sdn Bhd · Sep 1999
K992417 · ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR
Download PDF FDA Summary Shield Gloves Manufac…