Powder-Free Latex Examination Gloves - 18 Mils at Finger, Blue Color; 9 and 10 Mils at Finger, Natural Color
FDA 510(k) K072197 · Metacure Surgical Gloves Sdn Bhd
510(k) numberK072197
Submission
- Device name
- Powder-Free Latex Examination Gloves - 18 Mils at Finger, Blue Color; 9 and 10 Mils at Finger, Natural Color
- Applicant
- Metacure Surgical Gloves Sdn Bhd
Petaling Jaya, MY - Received
- August 7, 2007
- Decision date
- March 12, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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.
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|---|---|---|---|
| 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 |
|---|---|---|
| K073447 | Surgi GlovesKGO · Traditional | 04/24/2008SE |
Questions and answers
When was Powder-Free Latex Examination Gloves - 18 Mils at Finger, Blue Color; 9 and 10 Mils at Finger, Natural Color cleared by the FDA?
Powder-Free Latex Examination Gloves - 18 Mils at Finger, Blue Color; 9 and 10 Mils at Finger, Natural Color (K072197) received a 510(k) decision of Substantially Equivalent on March 12, 2008, 218 days after the submission was received.
What is the product code of K072197?
The FDA product code is LZC – Medical Glove, Specialty, a Class I (low risk) device regulated under 21 CFR 880.6250.