FDA.reportPublic FDA data

Dexters

Primary DI
26971787077685
Brand
Dexters
Company
Guilin HBM Health Protections, Inc.
Model
DPIG85
Catalog number
DPIG85
Device description
Sterile Synthetic Polyisoprene Powder-Free Surgical Gloves, SIZE 8.5
Published
2023-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K203483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203483000Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesGuilin Hbm Health Protections, Inc.2021-02-01KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26971787077685PackageGS14In Commercial Distribution
06971787077681PrimaryGS10
16971787077688Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697178707768526971787077685
06971787077681069717870776816971787077681
1697178707768816971787077688

GMDN Terms#

Term, Definition table
TermDefinition
Polyisoprene surgical glove, non-powdered, antimicrobialA device made of polyisoprene intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; it includes an antimicrobial or antiviral agent/properties to reduce viable-microbe exposure in case of sharp penetration and its inner surface is not covered with powder. It is used mainly as a two-way barrier to protect patient and staff from contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, elasticity) and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
553958608
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26971787077623DextersDPIG55DPIG552023-08-30
26971787077630DextersDPIG60DPIG602023-08-30
16971787077640DextersDPIG65DPIG652023-08-30
26971787077654DextersDPIG70DPIG702023-08-30
26971787077661DextersDPIG75DPIG752023-08-30
26971787077678DextersDPIG80DPIG802023-08-30
26971787077692DextersDPIG90DPIG902023-08-30

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Primary DI, Brand, Company table
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07323190091300Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091348Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091379Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091454Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
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