FDA.reportPublic FDA data

SafeTouch Sterile Latex Surgical Gloves, 7 1/2

Primary DI
00616784237510
Brand
SafeTouch Sterile Latex Surgical Gloves, 7 1/2
Company
Dynarex Corporation
Model
2375
Device description
Sterile-EO, Powder-Free / Cuffed
Published
2025-09-15
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
K000896000
K151114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000896000POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESSFitco Dipped Products Pvt., Ltd.2000-05-03KGO
K151114000Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with proteinSt. Marys Rubbers Pvt, Ltd.2015-12-11KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784237527PackageGS150In Commercial Distribution
00616784237534PackageGS14In Commercial Distribution
00616784237510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784237527006167842375276167842375270616784237527
00616784237534006167842375346167842375340616784237534
00616784237510006167842375106167842375100616784237510

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. 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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117346307Vital Signs Stand, Compatible with item 10843108562026-06-08
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)8150BLK2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)8161BLK2026-06-08
00840117327610Titan-700 Bariatric Rollator102172023-12-28
00840117325968Platform Attachment102122023-03-24
00840117326026Dynarex Bari + Max Bariatric Platform Attachment102132023-03-24
00616784020419Vivid-Flex, Adjustable Height Rollator102042019-10-07
00616784021515Compact Steerable Knee Walker, With Basket, Steel102152019-10-08
00616784021614Steerable Knee Walker with Basket102162019-10-08
00616784020815DynaGo Duo Transport Rollator With 7.5" Casters and Plastic Footrest102082019-11-13
00840117325913Bari + Max Bariatric HD Steel Walker, Weight Capacity 700 lb.101692023-01-09
00840117336483Steel Button Folding Walker with 5 Wheels, Adults101702024-06-17
00616784020013DynaGo Zoom - Aluminum Rollator with 3" Wheels102002019-10-07
00616784020112Vivid-Quad, Rollator, With 6" Caster , Blue10201BL2019-10-07
00616784020211Vivid-Terrain, Rollator with 7.5" Caster102022019-10-07
00616784020310Titan-500 Bariatric Rollator102032019-10-07
00616784020129Vivid-Quad, Rollator, With 6" Caster, Red10201RD2019-11-07
00616784020136Vivid-Quad, Rollator, With 6" Caster, Black10201BK2019-11-07
00616784020143Vivid-Quad, Rollator, With 6" Caster, Pink10201PK2019-11-07
00616784016016DMECare Solutions Two Button Folding Walker, Adult (32"-39")101602019-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09001570557278Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557940Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557971Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570558008Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557285Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557377Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557407Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557438Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557469Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557490Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570536686Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536693Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536709Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536716Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536723Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536730Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12