STEELFLEX · ANST355
American Nitrile Operations, LLC · STEELFLEX SIZE XL, Blue Nitrile Powder-Free, Chemo and Fentanyl Resistant Patient Examination Glove
Open FDA's page for this record- Has donation ID number
- false
- Mri safety
- Labeling does not contain MRI Safety Information
- Record status
- Published
- Is labeled as nrl
- false
- Is rx
- true
- Commercial distribution status
- In Commercial Distribution
- Device description
- STEELFLEX SIZE XL, Blue Nitrile Powder-Free, Chemo and Fentanyl Resistant Patient Examination Glove
- Public device record key
- 0708f887-f7e3-4e55-ad25-857a5ceac53c
- Has serial number
- false
- Public version date
- 2026-08-03
- Is direct marking exempt
- false
- Public version number
- 2
- Labeler duns number
- 118378851
- Is labeled as no nrl
- true
- Is single use
- true
- Is otc
- true
- Version or model number
- ANST355
- Has manufacturing date
- true
- Brand name
- STEELFLEX
- Is combination product
- false
- Is kit
- false
- Device count in base package
- 1
- Is pm exempt
- false
- Has lot or batch number
- true
- Catalog number
- ANST355
- Company name
- American Nitrile Operations, LLC
- Public version status
- Update
- Has expiration date
- false
- Is hct p
- false
- Publish date
- 2024-02-14
- Sterilization
- Is sterile
- false
- Is sterilization prior use
- false
- Identifiers
- ID
- 00850040723304
- Type
- Package
- Issuing agency
- GS1
- Unit of use ID
- 00850040723151
- Quantity per package
- 10
- Package status
- In Commercial Distribution
- Package type
- Case of 1800
- ID
- 00850040723151
- Type
- Primary
- Issuing agency
- GS1
- Product codes
- Code
- LZA
- Name
- Polymer Patient Examination Glove
- Harmonized identifiers (openFDA)
- Device name
- Polymer Patient Examination Glove
- Medical specialty description
- General Hospital
- Regulation number
- 880.6250
- Device class
- 1
- Code
- LZC
- Name
- Patient Examination Glove, Specialty
- Harmonized identifiers (openFDA)
- Device name
- Medical Glove, Specialty
- Medical specialty description
- General Hospital
- Regulation number
- 880.6250
- Device class
- 1
- Code
- QDO
- Name
- Fentanyl And Other Opioid Protection Glove
- Harmonized identifiers (openFDA)
- Device name
- Fentanyl And Other Opioid Protection Glove
- Medical specialty description
- General Hospital
- Regulation number
- 880.6250
- Device class
- 1
- Customer contacts
- Phone
- 614-600-2655
- xx@xx.xx
- Gmdn terms
- Code
- 56286
- Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Implantable
- false
- Code status
- Active
- Definition
A 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.