RoyalTouch

GUDID 10810007660155

Nitrile Powder Free Examination Gloves, M, Tested for Use with Chemotherapy Drugs.

HOURGLASS INTERNATIONAL INC

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID10810007660155
NIH Device Record Key5d6765c2-936d-4e7a-b1eb-a19b566485d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameRoyalTouch
Version Model Number302
Company DUNS026777252
Company NameHOURGLASS INTERNATIONAL INC
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
Special Storage Condition, SpecifyBetween 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.

Device Identifiers

Device Issuing AgencyDevice ID
GS110810007660155 [Unit of Use]
GS120810007660152 [Primary]

FDA Product Code

LZAPolymer Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-09
Device Publish Date2021-12-01

On-Brand Devices [RoyalTouch]

10810007660179Nitrile Powder Free Examination Gloves, XL, Tested for Use with Chemotherapy Drugs.
10810007660162Nitrile Powder Free Examination Gloves, L, Tested for Use with Chemotherapy Drugs.
10810007660155Nitrile Powder Free Examination Gloves, M, Tested for Use with Chemotherapy Drugs.
10810007660148Nitrile Powder Free Examination Gloves, S, Tested for Use with Chemotherapy Drugs.
10810007660131Nitrile Powder Free Examination Gloves, XS, Tested for Use with Chemotherapy Drugs.
00810007660172Nitrile Powder Free Examination Gloves, XL, Tested for Use with Chemotherapy Drugs.
00810007660165Nitrile Powder Free Examination Gloves, L, Tested for Use with Chemotherapy Drugs.
00810007660158Nitrile Powder Free Examination Gloves, M, Tested for Use with Chemotherapy Drugs.
00810007660141Nitrile Powder Free Examination Gloves, S, Tested for Use with Chemotherapy Drugs.
00810007660134Nitrile Powder Free Examination Gloves, XS, Tested for Use with Chemotherapy Drugs.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.