FDA.reportPublic FDA data

Safco Nitrilex Gloves

Primary DI
00810063754778
Brand
Safco Nitrilex Gloves
Company
SAFCO DENTAL SUPPLY CO.
Model
1028057
Catalog number
1028057
Device description
Safco Nitrilex powder-free nitrile gloves medium 100/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
10810063754775PrimaryGS10
00810063754778Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081006375477510810063754775
00810063754778008100637547788100637547780810063754778

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
100
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
20810063756240KIDS BUDDY Toothbrush8250071TK32025-03-19
20810063756257Power Curve Toothbrush82500830022025-03-19
20810063756264Esprit Ultra Fine Toothbrush82500872082025-03-19
20810063756271Whisper Tech Ultra-Fine Toothbrush82500926012025-03-19
20810063756288Power Curve Toothbrush8250093002-I2025-03-19
20810063756400Power Curve Extra-Soft Toothbrush8250094002XS2025-03-19
20810063756431KIDS BUDDY Toothbrush8250072TK3-I2025-03-19
20810063756585Jr Series Comfort Grip Toothbrush82500892402025-03-19
20810063756592Power Curve Extra-Soft Toothbrush8250095002XS-I2025-03-19
20810063755564Waxed Dental Floss8250016300062025-03-18
20810063756172Euro Tech Compact Sensitive Toothbrush8250007T1872025-03-18
20810063756189Waxed Dental Floss8250017300072025-03-18
20810063756196Floss Picks8250039FP2025-03-18
20810063756202Endeavor Toothbrush8250043T0202025-03-18
20810063756219Vital Fresh Toothbrush8250048T056-I2025-03-18
20810063756226Aspire Compact Toothbrush8250060T509-I2025-03-18
20810063756233PlaquePRO Interdental Proxy Brush8250066T5132025-03-18
20810063756394Polisher Compact Toothbrush8250058T4902025-03-18
20810063756530Soft Flex Toothbrush8250054T183-I2025-03-18
20810063756547Glisten Junior Toothbrush8250064T511-I2025-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G247CPMX10CPMX1Compremium AGLXC2025-05-19
07540162030093MY01 Mobile ApplicationMY01 IncLXC2025-04-29
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
00810063754747Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754761Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00850007350185Side Ported Needle - 20GC2DX, INC.LXC2022-05-03
00850007350192Quick Pressure Monitor Set (Japan) - 20GC2DX, INC.LXC2022-05-03
00843511121228Omnia Medical PsiFOMNIA MEDICAL, LLCLXC2021-10-14
07540162030017MY01 Continuous Compartmental Pressure MonitorMY01 IncLXC2021-03-01
00850007350055STIC Intracompartmental Pressure MonitorC2DX, INC.LXC2020-04-08
00850007350000Indwelling Slit CatheterC2DX, INC.LXC2020-04-08
00850007350017Quick Pressure Monitor SetC2DX, INC.LXC2020-04-08
00850007350024Quick Pressure Monitor Set (Japan)C2DX, INC.LXC2020-04-08
00850007350031Side Ported NeedleC2DX, INC.LXC2020-04-08
00850007350048Syringe, 3ccC2DX, INC.LXC2020-04-08
04546540052285NASTRYKER CORPORATIONLXC2018-09-24
34546540052316NASTRYKER CORPORATIONLXC2018-09-24
34546540892820NASTRYKER CORPORATIONLXC2018-09-24
34546540892851NASTRYKER CORPORATIONLXC2018-09-24
34546540052323NASTRYKER CORPORATIONLXC2017-07-12
H6795304110NASYNTHES (U.S.A.) LPLXC2016-12-31
H6795304120NASYNTHES (U.S.A.) LPLXC2016-12-31
H6795304130NASYNTHES (U.S.A.) LPLXC2016-12-31