FDA.reportPublic FDA data

SafeTouch Sterile Nitrile Surgical Gloves, Size 8

Primary DI
00616784653716
Brand
SafeTouch Sterile Nitrile Surgical Gloves, Size 8
Company
Dynarex Corporation
Model
6537
Device description
Cuffed and Powder-Free, 1 Pair per Package, Hand Specific
Published
2022-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122557000MOTEX POWDER-FREE NITRILE SURGICAL GLOVESShanghai Motex Healthcare Co., Ltd.2013-10-03KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784653723PackageGS150In Commercial Distribution
00616784653730PackageGS14In Commercial Distribution
00616784653716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784653723006167846537236167846537230616784653723
00616784653730006167846537306167846537300616784653730
00616784653716006167846537166167846537160616784653716

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile surgical glove, non-powderedA sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder and it does not have antimicrobial features. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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00616784316925Cotton Balls, Large31692026-10-01
00616784317021Cotton Balls, Medium31702026-10-01
00616784671628SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrou67162026-09-30
00616784671727SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67172026-09-30
00616784671826SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67182026-09-30
00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67192026-09-30
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00840117346239Resp-O2 M15 Oxygen Standard D-Cylinder, With CGA 870 Post Valve36391-PBULK2026-09-28
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00840117352735dmecare Solutions Folding Beside Commode103702021-04-22
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