FDA.reportPublic FDA data

Safco Nitrilex UltraSoft Gloves

Primary DI
00810063754747
Brand
Safco Nitrilex UltraSoft Gloves
Company
SAFCO DENTAL SUPPLY CO.
Model
1028018
Catalog number
1028018
Device description
Safco Nitrilex UltraSoft powder-free nitrile 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

Product Codes#

Code, Name table
CodeName
LXCMONITOR, PRESSURE, INTRACOMPARTMENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXCMonitor, Pressure, IntracompartmentalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810063754744PrimaryGS10
00810063754747Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081006375474410810063754744
00810063754747008100637547478100637547470810063754747

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D72310203523Prep&Etch™102-0352102-03522016-08-17
D72310203603Prep&Etch™102-0360102-03602016-08-17
D72310202123Safco TruCheck102021210202122022-06-17
D72310202133Safco TruCheck102021310202132023-07-31
D72310202153Safco TruCheck102021510202152022-06-17
D72310202173Safco TruCheck102021710202172022-06-17
D72310202183Safco TruCheck102021810202182023-07-31
D72310202193Safco TruCheck102021910202192022-06-17
D72310202213Safco TruCheck102022110202212022-06-17
D72310224053Safco Pure102240510224052022-03-30
10810063756243KIDS BUDDY Toothbrush8250071TK32025-03-19
10810063756250Power Curve Toothbrush82500830022025-03-19
10810063756267Esprit Ultra Fine Toothbrush82500872082025-03-19
10810063756274Whisper Tech Ultra-Fine Toothbrush82500926012025-03-19
10810063756281Power Curve Toothbrush8250093002-I2025-03-19
10810063756403Power Curve Extra-Soft Toothbrush8250094002XS2025-03-19
10810063756434KIDS BUDDY Toothbrush8250072TK3-I2025-03-19
10810063756588Jr Series Comfort Grip Toothbrush82500892402025-03-19
10810063756595Power Curve Extra-Soft Toothbrush8250095002XS-I2025-03-19
20810063756240KIDS BUDDY Toothbrush8250071TK32025-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G247CPMX10CPMX1Compremium AGLXC2025-05-19
07540162030093MY01 Mobile ApplicationMY01 IncLXC2025-04-29
10840199544223Rhoton Spetzler Type SetKOROS U.S.A., INC.LXC2022-12-31
10810063754652Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754669Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754676Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754683Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754690Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754706Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754713Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754720Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754737Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754744Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754751Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754768Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754775Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754782Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754799Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754812Safco Nitrilex Prevail GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754829Safco Nitrilex Prevail GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754843Safco Nitrilex Prevail GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754655Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754662Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754686Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754693Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754709Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754761Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754778Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
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10850007350182Side Ported Needle - 20GC2DX, INC.LXC2022-05-03