510(k) K973615
- Device
- SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES
- Applicant
- MACRO RUBBER INDUSTRIAL, INC.
- 510(k) number
- K973615
- Product code
- LYY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-05-20
- Date received
- 1997-09-23
- Regulation
- 880.6250
- Classification name
- Latex Patient Examination Glove
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code LYY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250069 | Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein | Comfort Rubber Gloves Industries Sdn. Bhd. | 2025-04-29 |
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural White) | Sri Trang Gloves (Thailand) Public Company Limited | 2024-09-09 |
| K230573 | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) | Kossan International Sdn Bhd | 2023-06-13 |
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) | Shandong Intco Medical Products Co, Ltd. | 2023-02-22 |
| K222612 | Powder-Free Latex examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-11-25 |
| K221667 | Non Sterile Powder Free Latex Examination Glove | New Era Medicare Sdn. Bhd. | 2022-10-28 |
| K222348 | JR MEDIC | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-10-27 |
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2022-10-26 |
| K222693 | Single-use medical latex examination gloves (LG100) | Fitone Latex Products Co., Ltd. Guangdong | 2022-09-24 |
| K221648 | Iconic Latex Glove | Iconic Medicare Sdn Bhd | 2022-08-25 |
| K211601 | Powder Free Latex Examination Glove, Non-Sterile | Wrp Asia Pacific Sdn. Bhd. | 2022-08-22 |
| K212482 | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White | Sri Trang Gloves (Thailand) Public Company Limited | 2022-08-09 |
| K214017 | Examination gloves-Type A(Latex gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | 2022-07-14 |
| K221185 | TC Gloves | Thanh Cong Pharmaceutical and Trading Company Limited | 2022-06-22 |
| K212597 | Amazing+ Latex Examination Powder Free Gloves | Amazing Rubber Products Pvt, Ltd. | 2022-05-28 |
Legacy Summary#
summary
FDA Review#
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