FDA Product Code
FDA Product Code LYY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6250
510(k) Clearances — 1,954 records · page 8 of 20
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K953462 | PATIENT EXAMINATION GLOVES | P.T. Irama Dinamika Latex | 1996-01-04 | Traditional | PDF ↗ |
| K954855 | POWDER FREE PLUS PATIENT EXAMINATION GLOVE | Tillotson Healthcare Corp. | 1995-12-28 | Traditional | PDF ↗ |
| K954365 | POWDER FREE LATEX EXAMINATION GLOVES | Perusahaan Getah Asas Sdn. Bhd. | 1995-12-11 | Traditional | PDF ↗ |
| K942855 | NON-CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES | Evergrade Healthcare Products Sdn Bhd | 1995-11-15 | Traditional | PDF ↗ |
| K954880 | LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION) | Siam Sempermed Corp., Ltd. | 1995-11-15 | Traditional | PDF ↗ |
| K954051 | SIME POWDERFREE PLUS | Sime Health, Ltd. | 1995-11-15 | Traditional | PDF ↗ |
| K953709 | DERRICK SAFETOUCH | M.P.S. Pharm'L Int'L | 1995-11-06 | Traditional | PDF ↗ |
| K954081 | PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE) | Tan Chong Rubber Gloves Sdn Bhd | 1995-10-30 | Traditional | PDF ↗ |
| K953986 | POWDERFREE LATEX GLOVE | Steriltx | 1995-10-19 | Traditional | PDF ↗ |
| K952473 | POWDER-FREE LATEX EXAMINATION GLOVE | M.M.R. Gloves Private , Ltd. | 1995-10-12 | Traditional | PDF ↗ |
| K952588 | ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES | Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. | 1995-10-12 | Traditional | PDF ↗ |
| K953740 | FOR MED HIGH RISK | For Med, Inc. | 1995-10-12 | Traditional | PDF ↗ |
| K945506 | ACRYLIC DIPPED LATEX EXAMINATION GLOVES | Ganz Industries Sdn. Bhd. | 1995-10-12 | Traditional | PDF ↗ |
| K953379 | HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE | Ansell, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K953138 | MEDI-PLUS, HEALTH PLUS, SANITEX, RELIANCE | Pwa Industries Sdn. Bhd. | 1995-09-22 | Traditional | PDF ↗ |
| K953496 | ROYAL SHIELD NON-STERILE POWDER-FREE HYPOALLERGENIC LATEX EXAMINATION GLOVES | Shield Gloves Manufacturer (M) Sdn Bhd | 1995-09-08 | Traditional | PDF ↗ |
| K952833 | AMPRI | Ampri Rubberware Industries Sdn Bhd | 1995-09-05 | Traditional | PDF ↗ |
| K951018 | LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER | Siam Sempermed Corp., Ltd. | 1995-08-28 | Traditional | PDF ↗ |
| K945504 | ACRYLIC DIPPED LATEX EXAMINATION GLOVES - STERILE | Ganz Industries Sdn. Bhd. | 1995-08-18 | Traditional | PDF ↗ |
| K952590 | ROYAL SHIELD NON-STERILE PINK COLOERED, STRAWBERRY SCENTED LATEX EXAMINATION GLOVES | Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. | 1995-08-14 | Traditional | PDF ↗ |
| K952197 | GLOVETEX (MULTIPLE) | Pt Mbf Buana Multicorpora | 1995-08-14 | Traditional | PDF ↗ |
| K952591 | ROYAL SHIELD NON-STERILE BLUE COLORED BUBBLE GUM SCENTED LATEX EXAMINATION GLOVES | Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. | 1995-08-11 | Traditional | PDF ↗ |
| K952589 | ROYAL SHIELD PINK & BLUE COLORED NON-STERILE LATEX EXAMINATION GLOVES | Shield Gloves Manufacturer (M) Sdn Bhd | 1995-08-11 | Traditional | PDF ↗ |
| K952851 | SAFESKIN | Safeskin Corp. | 1995-08-11 | Traditional | PDF ↗ |
| K952793 | SAFESKIN | Safeskin Corp. | 1995-08-11 | Traditional | PDF ↗ |
| K952695 | BOSTON MEDICAL LATEX EXAM GLOVES | Shun Thai Rubber Gloves Industry Co., Ltd. | 1995-08-11 | Traditional | PDF ↗ |
| K945766 | HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES | Ansell, Inc. | 1995-08-07 | Traditional | PDF ↗ |
| K953299 | POLYKOTE | Intl. Trade Management Co. | 1995-08-07 | Traditional | PDF ↗ |
| K952404 | SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE | Aladan Corp. | 1995-07-20 | Traditional | PDF ↗ |
| K946056 | ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE) | Ampri Rubberware Industries Sdn Bhd | 1995-07-20 | Traditional | PDF ↗ |
| K952367 | CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE | Cypress Medical Products, Ltd. | 1995-07-05 | Traditional | PDF ↗ |
| K951940 | PATIENT EXAMINATION GLOVE | Lowenkamp Intl., Inc. | 1995-06-28 | Traditional | PDF ↗ |
| K952556 | SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE | Aladan Corp. | 1995-06-26 | Traditional | PDF ↗ |
| K950357 | SURVIVAL KIT | Opportunity Resources, Inc. | 1995-06-22 | Traditional | PDF ↗ |
| K951839 | ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES | Aladan Corp. | 1995-06-15 | Traditional | PDF ↗ |
| K951670 | DISPOSABLE LATEX PATIENT EXAMINATION GLOVES | Emi Groups (U.S.A.), Inc. | 1995-06-15 | Traditional | PDF ↗ |
| K952335 | WOUND CARE MANAGEMENT KITS | Continental Medical Laboratories, Inc. | 1995-06-14 | Traditional | PDF ↗ |
| K946257 | LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC) | Siam Sempermed Corp., Ltd. | 1995-06-08 | Traditional | PDF ↗ |
| K950450 | POWDER FREE LATEX EXAMINATION GLOVES | Rampart Glove Co. | 1995-06-02 | Traditional | PDF ↗ |
| K950622 | MEGA MEDITEX LIMITED | Mega Meditex , Ltd. | 1995-06-02 | Traditional | PDF ↗ |
| K951513 | JAI | Intl. Trade Management Co. | 1995-05-25 | Traditional | PDF ↗ |
| K951667 | COMFIT/GREEN POWDERED EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1995-05-17 | Traditional | PDF ↗ |
| K951668 | SCIPOTEX/POWDER FREE EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1995-05-17 | Traditional | PDF ↗ |
| K943601 | COMFIT (PINK) | Wembley Rubber Products (M) Sdn Bhd | 1995-05-17 | Traditional | PDF ↗ |
| K950823 | ANDAL | Pt. Sarana Indoprotex | 1995-05-10 | Traditional | PDF ↗ |
| K951468 | COMFIT | Wembley Rubber Products (M) Sdn Bhd | 1995-04-28 | Traditional | PDF ↗ |
| K951456 | SCIPOTEX (BLUE) | Wembley Rubber Products (M) Sdn Bhd | 1995-04-28 | Traditional | PDF ↗ |
| K945785 | SCIPOTEX | Wembley Rubber Products (M) Sdn Bhd | 1995-04-28 | Traditional | PDF ↗ |
| K951467 | ULTIMAX | Wembley Rubber Products (M) Sdn Bhd | 1995-04-28 | Traditional | PDF ↗ |
| K951455 | SCIPOTEX (PINK) | Wembley Rubber Products (M) Sdn Bhd | 1995-04-28 | Traditional | PDF ↗ |
| K946111 | PROSHIELD PLUS MULTIPLE | Sino (U.S.A.) Co. | 1995-04-25 | Traditional | PDF ↗ |
| K950467 | POWDER FREE PATIENT EXAMINATION GLOVES | Intl. Trade Management Co. | 1995-04-25 | Traditional | PDF ↗ |
| K936266 | COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC) | Wembley Rubber Products (M) Sdn Bhd | 1995-04-13 | Traditional | PDF ↗ |
| K951137 | COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC) | Wembley Rubber Products (M) Sdn Bhd | 1995-04-13 | Traditional | PDF ↗ |
| K951171 | SCIPOTEX | Wembley Rubber Products (M) Sdn Bhd | 1995-04-13 | Traditional | PDF ↗ |
| K950254 | CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE | Cypress Medical Products, Ltd. | 1995-03-31 | Traditional | PDF ↗ |
| K945885 | PATIENT EXAMINATION GLOVES | Hartalega Sdn Bhd | 1995-03-23 | Traditional | PDF ↗ |
| K943563 | COMFIT BLUE POWDER FREE EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1995-03-07 | Traditional | PDF ↗ |
| K945767 | POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES | Ansell, Inc. | 1995-03-02 | Traditional | PDF ↗ |
| K941557 | DISPOSABLE LATEX EXAM GLOVES | Dah Lee Investments, Ltd. | 1995-02-28 | Traditional | PDF ↗ |
| K946203 | JAI POWDERFREE LATEX EXAMINATION GLOVES | Intl. Trade Management Co. | 1995-02-27 | Traditional | PDF ↗ |
| K943451 | ULTIMAX POWDER FREE EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1995-02-24 | Traditional | PDF ↗ |
| K936295 | COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC) | Wembley Rubber Products | 1995-02-24 | Traditional | PDF ↗ |
| K943869 | ULTIMAX (GREEN POWDER FREE EXAMINATION) | Wembley Rubber Products (M) Sdn Bhd | 1995-02-21 | Traditional | PDF ↗ |
| K943868 | SCIPOTEX | Wembley Rubber Products (M) Sdn Bhd | 1995-02-03 | Traditional | PDF ↗ |
| K945164 | MULTIPLE | Protection Gloves Sdn. Bhd. | 1995-02-03 | Traditional | PDF ↗ |
| K942511 | SCIPOTEX POWDER FREE EXAM GLOVES (BEADED) | Wembley Rubber Products (M) Sdn Bhd | 1995-02-03 | Traditional | PDF ↗ |
| K946155 | LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE) | Mala Intertrade Co., Ltd. | 1995-01-17 | Traditional | PDF ↗ |
| K945031 | ROYALSHIELD NON-STERILE POWDER-FREE | Shield Gloves Manufacturer (M) Sdn Bhd | 1995-01-11 | Traditional | PDF ↗ |
| K946154 | MALA LATEX EXAM GLOVES AND SCAN-SUB | Lowenkamp Intl., Inc. | 1995-01-11 | Traditional | PDF ↗ |
| K933602 | PATIENT EXAMINATION GLOVE | Kerala Rubber & Reclaims, Ltd. | 1995-01-02 | Traditional | PDF ↗ |
| K945045 | PATIENT EXAINATION GLOVES | Phoenix Medical Technology, Inc. | 1995-01-02 | Traditional | PDF ↗ |
| K945247 | POWDERFREE LATEX EXAMINATION GLOVE | Sri Johani Sdn. Bhd. | 1995-01-02 | Traditional | PDF ↗ |
| K943839 | STERMED NON-CHLORINATED POWDER FREE GLOVES | Steriltx (Usa), Inc. | 1994-12-19 | Traditional | PDF ↗ |
| K944139 | DENTAL HYGIENE TRAY | Sterile Concepts, Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K932521 | POWDERFREE LATEX EXAMINATION GLOVES | Top Glove Sdn. Bhd. | 1994-12-13 | Traditional | PDF ↗ |
| K943900 | LATEX MEDICAL GLOVE | Johnson & Johnson Medical, Inc. | 1994-12-12 | Traditional | PDF ↗ |
| K945490 | LATEX EXAMINATION GLOVE | Masif Healthcare Products Sdn. Bhd. | 1994-12-08 | Traditional | PDF ↗ |
| K943858 | POWDER FREE (SILICONIZED) EXAM GLOVES | Crocker Industrial Resources Sdn. Bhd. | 1994-12-08 | Traditional | PDF ↗ |
| K943552 | POWDER-FREE GLOVES | Healthcare Gloves Sdn Bhd | 1994-12-08 | Traditional | PDF ↗ |
| K936268 | COMFIT BLUE POWDERED EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1994-12-07 | Traditional | PDF ↗ |
| K944140 | COMFIT | Wembley Rubber Products (M) Sdn Bhd | 1994-12-07 | Traditional | PDF ↗ |
| K942856 | POWDER-FREE LATEX EXAMINATION GLOVES | Pacificlink Exp.Industries Private , Ltd. | 1994-12-07 | Traditional | PDF ↗ |
| K942947 | COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC | Wembley Rubber Products (M) Sdn Bhd | 1994-11-30 | Traditional | PDF ↗ |
| K943707 | LATEX EXAMINATION GLOVES | Arista Latindo Industrial Ltd. P.T | 1994-11-30 | Traditional | PDF ↗ |
| K944095 | P2 NITRILE EXAM GLOVES | Biosafety Systems, Inc. | 1994-10-28 | Traditional | PDF ↗ |
| K944142 | P2 EXAM GLOVES | Biosafety Systems, Inc. | 1994-10-28 | Traditional | PDF ↗ |
| K941787 | LATEX EXAM GLOVES | P.T. Irama Dinamika Latex | 1994-10-19 | Traditional | PDF ↗ |
| K944141 | COMFIT (STERILE) | Wembley Rubber Products (M) Sdn Bhd | 1994-10-13 | Traditional | PDF ↗ |
| K942149 | POWDERED DISPOSABLE LATEX EXAM GLOVES/ANNEXURES | Ti-Mate Prophylactic Devices , Ltd. | 1994-10-13 | Traditional | PDF ↗ |
| K942877 | EXAMINATION GLOVES | Masif Healthcare Products Sdn. Bhd. | 1994-10-07 | Traditional | PDF ↗ |
| K942643 | ENSURE POWDER-FREE LATEX PATIENT EXAMINATION GLOVES | Basic Intl., Inc. | 1994-10-07 | Traditional | PDF ↗ |
| K943807 | ROYAL SHIELD PINK COLORED NON-STERILE LATEX EXAMINATION GLOVE | Shield Gloves Manufacturer (M) Sdn Bhd | 1994-09-29 | Traditional | PDF ↗ |
| K943044 | ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-STRAWBERRY | Shield Gloves Manufacturer (M) Sdn Bhd | 1994-09-26 | Traditional | PDF ↗ |
| K943043 | ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-BUBBLE GUM | Shield Gloves Manufacturer (M) Sdn Bhd | 1994-09-26 | Traditional | PDF ↗ |
| K943434 | PATIENT EXAMINATION GLOVES | Pacewell Sdn Bhd | 1994-09-26 | Traditional | PDF ↗ |
| K935384 | EXAMINATION GLOVES, POWDER FREE | Jf Trading Co., Ltd. | 1994-09-19 | Traditional | PDF ↗ |
| K932550 | POWDER FREE EXAMINATION GLOVES | Unigloves , Ltd. | 1994-09-19 | Traditional | PDF ↗ |
| K943735 | PROSHIELD PLUS MULTIPLE GLOVES | Sino (U.S.A.) Co. | 1994-09-16 | Traditional | PDF ↗ |
| K943620 | MICRO-TOUCH LATEX MEDICAL GLOVES | Johnson & Johnson Medical, Inc. | 1994-09-09 | Traditional | PDF ↗ |
Product code LYY · Class I · General Hospital. Data: openFDA.