Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LYU — Predicate Candidate Screening
56 FDA 510(k) clearances under this product code; the 50 most recent screened below.
133 daysmedian FDA review time
348 days90th percentile
56clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011755 | STRYKER T4 HYTREL (R) TOGAS | Stryker Corp. | 2001-06-22 | 16 | 0 |
| K965237 | NURSES BOUFFANT CAP | Copioumed Intl., Inc. | 1997-08-27 | 239 | 0 |
| K970988 | FAR-EAST BOUFFANT CAPS | Far East Science & Technology Development Co., Ltd. | 1997-07-10 | 114 | 0 |
| K964364 | DISPOSABLE APRON | Instrument Makar, Inc. | 1997-02-25 | 116 | 0 |
| K961791 | DEPUY DISPOSABLE FILTER/HOOD | Depuy, Inc. | 1996-08-09 | 92 | 0 |
| K961454 | AMMI MAGNI-GUARD | American Medical Mfg., Inc. | 1996-07-25 | 101 | 0 |
| K945302 | SLOAN STA-DRI PANT PROTECTOR | Sloan Corp. | 1996-03-19 | 567 | 0 |
| K954314 | ULTRAFIT LINERS | Stahmer Weston Scientific | 1995-12-28 | 104 | 0 |
| K953089 | I-SPOUSE | Products For Medicine | 1995-10-16 | 105 | 0 |
| K952303 | SPLASH ASSIST | Innovative Outsourcing Solutions | 1995-08-24 | 100 | 0 |
| K942200 | ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS | Thantex Specialties, Inc. | 1995-08-07 | 459 | 0 |
| K944276 | SLOAN STA-DRI BOOTLEG LEGGING | Sloan Corp. | 1995-07-31 | 335 | 0 |
| K944118 | SLOAN STA-DRI SURGICAL JUMPSUIT | Sloan Corp. | 1995-07-31 | 342 | 0 |
| K946003 | INTEC FULL FACE SHIELD | Intec Industries, Inc. | 1995-06-28 | 201 | 0 |
| K951420 | INCASE EXTENSIBLE BAG--NON-STERILE | Alpha Surgical, Inc. | 1995-06-08 | 73 | 0 |
| K944763 | CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE L | Wells Lamont Corp. | 1995-04-10 | 195 | 0 |
| K945098 | OP-D-OP II | Op-D-Op Visor Shields, Inc. | 1995-02-28 | 133 | 0 |
| K942828 | MAKAR FULL AND HALF FACE SHIELD | Instrument Makar, Inc. | 1995-02-23 | 254 | 0 |
| K943809 | MONOGARD FACE SHIELD | White Knight Healthcare | 1994-11-28 | 116 | 0 |
| K940228 | BOUFFANT CAP | Derekduck Industries Corp. | 1994-09-26 | 255 | 0 |
| K940226 | SHOE COVER | Derekduck Industries Corp. | 1994-09-26 | 255 | 0 |
| K940723 | BODY BOOT | Mark-Clark | 1994-09-06 | 200 | 0 |
| K941932 | SPLASH MASK | Incon Diversified Industries, Inc. | 1994-07-19 | 90 | 0 |
| K942022 | FACE-IT SHIELD | Onyx Medical Corp. | 1994-07-08 | 73 | 0 |
| K932953 | DERMAL GLOVES | George Glove Company, Inc. | 1994-06-24 | 372 | 0 |
| K940274 | NYLON LINER GLOVES | Wells Lamont Corp. | 1994-05-12 | 111 | 0 |
| K935158 | KACEY DISPOSABLE GLOVE LINER | K & C Medical, Inc. | 1994-04-20 | 174 | 0 |
| K931042 | MOORE SECURE CAP | Kerma Medical Products, Inc. | 1994-04-13 | 408 | 0 |
| K935723 | SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD | Cabot Safety Corp. | 1994-04-06 | 133 | 0 |
| K934842 | TECNOL SPLASHGUARD | Tecnol Medical Products, Inc. | 1994-03-09 | 152 | 0 |
| K931094 | PROCEL(TM) DERMALINER GLOVE | W. L. Gore & Associates, Inc. | 1994-02-14 | 348 | 0 |
| K935779 | AGAFAR FACE SHIELD | Infection Control Products, Inc. | 1994-02-01 | 60 | 0 |
| K931288 | ISOLAIR 2 FULL FACE SPLASH GUARD | Louis M. Gerson Co., Inc. | 1994-01-21 | 315 | 0 |
| K926438 | ACTION MEDTEK FACE SHIELD | Action Eyewear Corp. | 1993-08-18 | 238 | 0 |
| K925290 | CATALOG NUMBER 111 (FACESHIELD) | Ansley Medical Products, Inc. | 1993-07-23 | 275 | 0 |
| K925628 | ULTRATUFF CUT RESISTANT GLOVE LINER | Baxter Healthcare Corp | 1993-07-09 | 245 | 0 |
| K922407 | WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS | Wells Lamont Corp. | 1993-06-15 | 390 | 0 |
| K923229 | MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE | Medical Armor Corp. | 1993-05-07 | 310 | 0 |
| K915415 | GUARDALL SHIELD | Anago, Inc. | 1992-10-15 | 321 | 0 |
| K915056 | FINGGUARD | Allied Signal, Inc. | 1992-02-03 | 87 | 0 |
| K914077 | REPEL(TM) LITE CUT RESISTANT GLOVE LINERS | Depuy-Raynham | 1991-12-02 | 82 | 0 |
| K912737 | MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV | Medical Armor Corp. | 1991-10-08 | 109 | 0 |
| K912457 | MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO | Medical Armor Corp. | 1991-10-04 | 123 | 0 |
| K910890 | NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER | Lovell-Schenck, Inc. | 1991-06-27 | 128 | 0 |
| K911742 | OP-D-OP VISOR SHIELDS | Op-D-Op, Inc. | 1991-06-07 | 50 | 0 |
| K904903 | PARADERM(TM) SURGEON'S GLOVE ACCESSORY | Lovell-Schenck, Inc. | 1991-01-08 | 71 | 0 |
| K900425 | SURGICAL COTTON GLOVES | Allo Pro Corp. | 1990-09-07 | 220 | 0 |
| K902633 | CUT RESISTANT GLOVE LINER | Biomet, Inc. | 1990-07-27 | 43 | 1 |
| K901221 | PHYSICIAN BARRIER GLOVE, SURGICAL | Dynamic Marketing Ent. | 1990-07-10 | 118 | 0 |
| K902016 | MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE | Aor-Sullivan | 1990-05-16 | 16 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda