FDA.report

Safco DuraSoft Latex Gloves

Primary DI
D72310280350
Brand
Safco DuraSoft Latex Gloves
Company
SAFCO DENTAL SUPPLY CO.
Model
1028035
Catalog number
1028035
Device description
Safco DuraSoft latex gloves, small, 100/box
Published
2022-11-30
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
LYYLatex patient examination glove

Product Code Classifications

CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D72310280353PrimaryHIBCC0
D72310280350Unit of UseHIBCC0

GMDN Terms

TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods

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
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
D77116100LG0GuardianICP, INC.LYY2026-03-19
D77116100MD0GuardianICP, INC.LYY2026-03-19
D77116100SM0GuardianICP, INC.LYY2026-03-19
D77116100XL0GuardianICP, INC.LYY2026-03-19
D77116100XS0GuardianICP, INC.LYY2026-03-19
40080196762744MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
40080196762751MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
40080196762775MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
10888277703582MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
00810094090913ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090920ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090937ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090944ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090951ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
D1057115XS9MacTouch Surgimac LLCLYY2025-08-14
D1057115XSCS9MacTouch Surgimac LLCLYY2025-08-14
D1057116S9MacTouch Surgimac LLCLYY2025-08-14
D1057116SCS9MacTouch Surgimac LLCLYY2025-08-14
D1057117M9MacTouch Surgimac LLCLYY2025-08-14
D1057117MCS9MacTouch Surgimac LLCLYY2025-08-14
D1057118L9MacTouch Surgimac LLCLYY2025-08-14
D1057118LCS9MacTouch Surgimac LLCLYY2025-08-14
D1057119XL9MacTouch Surgimac LLCLYY2025-08-14
D1057119XLCS9MacTouch Surgimac LLCLYY2025-08-14
20742061700232KVPKVP International, Inc.LYY2025-08-12
20742061700249KVPKVP International, Inc.LYY2025-08-12
00742061700252KVPKVP International, Inc.LYY2025-08-12
20742061700263KVPKVP International, Inc.LYY2025-08-12
10076490456518TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
20076490001463TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30