FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESP RADIATION REDUCTION EXAMINATION GLOVES
K Number: K891968
·
Decision May 22, 1989
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
78
Applicant Total
432
Review Days
54
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ESP RADIATION REDUCTION EXAMINATION GLOVES
- K Number
- K891968
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Boston Scientific Corp
- Date Received
- March 29, 1989
- Decision Date
- May 22, 1989
- Product Code
- LZC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZC | Medical Glove, Specialty | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZC), ordered by most recent decision date.
Cardinal Health Nitrile Examination Gloves Extended Cuff
FDA 510(k)
FDA Class 1
·General Hospital
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
FDA 510(k)
FDA Class 1
·General Hospital
JR Medic
FDA 510(k)
FDA Class 1
·General Hospital
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
FDA 510(k)
FDA Class 1
·General Hospital
Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Boston Scientific Corp
| K Number | Device Name | ||
|---|---|---|---|
| K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) | Oct 18, 2024 | Substantially Equivalent |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Aug 19, 2023 | Substantially Equivalent |
| K152853 | WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary | Nov 20, 2015 | Substantially Equivalent |
| K150692 | AXIOS Stent with Electrocautery Enhanced Delivery System | Aug 5, 2015 | Substantially Equivalent |
| K150303 | XXL Vascular Balloon Dilatation Catheter | Jun 15, 2015 | Substantially Equivalent |
| K150186 | Chariot Guiding Sheath | Jun 5, 2015 | Substantially Equivalent |
| K150679 | EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector | May 29, 2015 | Unknown |
| K141820 | JAGWIRE HIGH PERFORMANCE GUIDWIRE | Oct 21, 2014 | Substantially Equivalent |
| K141344 | EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM | Oct 17, 2014 | Substantially Equivalent |
| K141335 | EXPEL APD DRAINAGE CATHETER SYSTEM | Oct 17, 2014 | Substantially Equivalent |