FDA.report

Safco Nitrilex Black Gloves

Primary DI
00810063754693
Brand
Safco Nitrilex Black Gloves
Company
SAFCO DENTAL SUPPLY CO.
Model
1027980
Catalog number
1027980
Device description
Safco Nitrilex Black powder-free gloves x-large 200/box
Published
2022-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LXCMONITOR, PRESSURE, INTRACOMPARTMENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
LXCMonitor, Pressure, IntracompartmentalUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810063754690PrimaryGS10
00810063754693Unit of UseGS10

GMDN Terms

TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; 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 patient/staff against 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, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
020417380
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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