HandPro 400

GUDID 20810007660503

HandPro Latex Exam Powder Free Gloves 100/BX , L

HOURGLASS INTERNATIONAL INC

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID20810007660503
NIH Device Record Key1adb319c-2dc5-4c2b-be2b-3013ce07aba1
Commercial Distribution StatusIn Commercial Distribution
Brand NameHandPro 400
Version Model Number403
Company DUNS026777252
Company NameHOURGLASS INTERNATIONAL INC
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
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 Latextrue
Labeled No Natural Rubber Latexfalse
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.

Device Identifiers

Device Issuing AgencyDevice ID
GS100810007660509 [Unit of Use]
GS110810007660506 [Primary]
GS120810007660503 [Package]
Contains: 10810007660506
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

LYYLatex 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 Date2022-09-20
Device Publish Date2022-09-12

On-Brand Devices [HandPro 400]

20857122007981HandPro Latex Exam Powder Free Gloves 4/PK, XL, Sample Pack
20857122007974HandPro Latex Exam Powder Free Gloves 4/PK, L, Sample Pack
00857122007963HandPro Latex Exam Powder Free Gloves 4/PK, M, Sample Pack
00857122007956HandPro Latex Exam Powder Free Gloves 4/PK, S, Sample Pack
00857122007949HandPro Latex Exam Powder Free Gloves 4/PK, XS, Sample Pack
20810007660510HandPro Latex Exam Powder Free Gloves 80/BX , XL
20810007660503HandPro Latex Exam Powder Free Gloves 100/BX , L
20810007660497HandPro Latex Exam Powder Free Gloves 100/BX , M
20810007660480HandPro Latex Exam Powder Free Gloves 100/BX , S
20810007660473HandPro Latex Exam Powder Free Gloves 100/BX , XS

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