FDA.report

Dexters

Primary DI
16971787077640
Brand
Dexters
Company
Guilin HBM Health Protections, Inc.
Model
DPIG65
Catalog number
DPIG65
Device description
POLYISOPRENE SURGICAL GLOVES STERILE & POWDER FREE, SIZE 6.5
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

Related Records

Product Codes

CodeName
KGOSurgeon'S Gloves

Product Code Classifications

CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions

SubmissionSupplement
K203483000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
26971787077647PackageGS14In Commercial Distribution
06971787077643PrimaryGS10
16971787077640Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2697178707764726971787077647
06971787077643069717870776436971787077643
1697178707764016971787077640

GMDN Terms

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

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 DIBrandModelCatalogPublished
26971787077623DextersDPIG55DPIG552023-08-30
26971787077630DextersDPIG60DPIG602023-08-30
26971787077654DextersDPIG70DPIG702023-08-30
26971787077661DextersDPIG75DPIG752023-08-30
26971787077678DextersDPIG80DPIG802023-08-30
26971787077685DextersDPIG85DPIG852023-08-30
26971787077692DextersDPIG90DPIG902023-08-30

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