Nitrile Gloves
FDA 510(k) K970135 · Sage Products, Inc.
510(k) numberK970135
Submission
- Device name
- Nitrile Gloves
- Applicant
- Sage Products, Inc.
Crystal Lake, IL, US - Received
- January 15, 1997
- Decision date
- August 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZC – Medical Glove, Specialty
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
A disposable medical glove (examination or surgeons) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.
Other 510(k)s with product code LZC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252313 | Cardinal Health Nitrile Examination Gloves Extended CuffLZC · Traditional | Cardinalhealth | 01/14/2026SE |
| K243959 | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with…LZC · Traditional | Lingshi Hongruida Health Protection Technology… | 02/24/2025SE |
| K221157 | JR MedicLZC · Abbreviated | Jr Engineering & Medical Technologies (M) Sdn.… | 08/30/2022SE |
| K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And…LZC · Traditional | Better Care Plastic Technology Co., Ltd. | 08/27/2022SE |
| K220545 | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsLZC · Traditional | Hl Rubber Industries Sdn Bhd | 05/26/2022SE |
| K220491 | Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsLZC · Traditional | Hainan Asther Medical Equipment Co., Ltd. | 05/14/2022SE |
| K220353 | Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy DrugsLZC · Traditional | Niujian Technology Co., Ltd. | 03/31/2022SE |
| K213910 | Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy DrugsLZC · Traditional | Changzhou Universal Medical Equipment Co., Ltd. | 03/10/2022SE |
| K213325 | Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy DrugsLZC · Traditional | Anhui Xinyisheng Medical Technology Co.,Ltd | 01/28/2022SE |
| K213076 | AspenMed+LZC · Abbreviated | Aspen Glove Sdn. Bhd. | 12/20/2021SE |
More from Aspen Glove Sdn. Bhd.
| 510(k) | Device | Decision |
|---|---|---|
| K972705 | Resheather Device-Metal or Plastic, Resheater/ Needle Holder Device-PlasticFMI · Traditional | 04/30/1998SE |
| K980490 | Sage Products Inc, Sharps Disposal Containers with Screw Top CapsMMK · Traditional | 02/24/1998SE |
| K973911 | 2 Gallon Alternate Care Sharps ContainerFMI · Traditional | 10/29/1997SE |
| K972279 | Sharps ShuttleFMI · Traditional | 08/29/1997SE |
| K972302 | Pocket Count or SafetcountLWH · Traditional | 07/25/1997SE |
| K964168 | Procedure Specific KitsFXX · Traditional | 03/03/1997SE |
| K963986 | STP System Pva with ZincLIO · Traditional | 11/08/1996SE |
| K964026 | STP System - SafLIO · Traditional | 11/07/1996SE |
| K964027 | STP System-Pva with MercuryLIO · Traditional | 11/01/1996SE |
| K962168 | Mucus Specimen TrapKDQ · Traditional | 07/22/1996SE |
Questions and answers
When was Nitrile Gloves cleared by the FDA?
Nitrile Gloves (K970135) received a 510(k) decision of Substantially Equivalent on August 25, 1997, 222 days after the submission was received.
What is the product code of K970135?
The FDA product code is LZC – Medical Glove, Specialty, a Class I (low risk) device regulated under 21 CFR 880.6250.