Islander Eyes
Islander Eyes $19.95 Polarized Sunglasses
522manufacturers in China registered for this device type
68catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (254), Guangdong (112), Jiangsu (49). 53 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Wenzhou Weilan Optical Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 8 |
| Taizhou Rapson Glasses Co., Ltd. | Linhai | Zhejiang | Contract manufacturer | 6 |
| Wenzhou Summer International Limited | Wenzhou | Zhejiang | Contract manufacturer | 6 |
| Danyang Rimesis Optical Glasses Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 5 |
| Jiangsu Yuchang Optical Glasses Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 5 |
| Wenzhou Kangjing Optics Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 5 |
| Wenzhou Mingshida Light Industrial Products Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 5 |
| Wenzhou Rainbow Optical Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 5 |
| Wenzhou Zengtai Industry AND Trade Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 5 |
| Zhejiang Yinfeng Glasses Co., Ltd. | Linhai, Taizhou | Zhejiang | Contract manufacturer | 5 |
| Dong Guan Gang MEI Optical Limited | Dong Guan | Guangdong | Contract manufacturer | 4 |
Showing 12 of 522. All 522 manufacturers in China registered for Sunglasses (Non-Prescription Including Photosensitive)
Record
| Listed by | Cliff Weil, Inc., United States |
|---|---|
| FDA product code | HQY |
| Device type | Sunglasses (Non-Prescription Including Photosensitive) |
| Device class | Class 1 |
| Regulation | 21 CFR 886.5850 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-10-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 474 | In distribution | |
| 414 | In distribution | |
| 453 | In distribution | |
| 437 | In distribution | |
| 428 | In distribution | |
| 418 | In distribution | |
| 480 | In distribution | |
| 413 | In distribution | |
| 462 | In distribution | |
| 456 | In distribution | |
| 410 | In distribution | |
| 450 | In distribution | |
| 473 | In distribution | |
| 478 | In distribution | |
| 412 | In distribution | |
| 433 | In distribution | |
| 444 | In distribution | |
| 475 | In distribution | |
| IE1995 | In distribution | |
| 493 | In distribution | |
| 452 | In distribution | |
| 421 | In distribution | |
| 459 | In distribution | |
| 431 | In distribution | |
| 420 | In distribution | |
| 454 | In distribution | |
| 468 | In distribution | |
| 484 | In distribution | |
| 471 | In distribution | |
| 436 | In distribution | |
| 491 | In distribution | |
| 430 | In distribution | |
| 434 | In distribution | |
| 415 | In distribution | |
| 416 | In distribution | |
| 443 | In distribution | |
| 435 | In distribution | |
| 486 | In distribution | |
| 424 | In distribution | |
| 419 | In distribution | |
| 426 | In distribution | |
| 477 | In distribution | |
| 451 | In distribution | |
| 481 | In distribution | |
| 469 | In distribution | |
| 482 | In distribution | |
| 411 | In distribution | |
| 448 | In distribution | |
| IE1495 | In distribution | |
| 494 | In distribution | |
| 422 | In distribution | |
| IE1699 | In distribution | |
| 458 | In distribution | |
| 485 | In distribution | |
| 472 | In distribution | |
| 423 | In distribution | |
| 425 | In distribution | |
| 432 | In distribution | |
| 417 | In distribution | |
| 467 | In distribution | |
| 445 | In distribution | |
| 427 | In distribution | |
| 446 | In distribution | |
| 449 | In distribution | |
| 492 | In distribution | |
| 442 | In distribution | |
| 438 | In distribution | |
| IE2199 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Foster Grant | FGX International Inc. | 6,128 |
| Unbranded | FGX International Inc. | 1,977 |
| Etnia Eyewear Culture | Etnia Barcelona, Llc. | 1,756 |
| UVShield, NoIR, GlareShield | NoIR | 1,547 |
| Solar Shield | FGX International Inc. | 1,529 |
| Panama Jack | FGX International Inc. | 1,297 |
| Assorted Brands | FGX International Inc. | 1,206 |
| Sunglasses | Taizhou Yuanming Glasses Co., Ltd. | 1,172 |
| Nine West | FGX International Inc. | 1,105 |
| Ironman | FGX International Inc. | 1,086 |
| Vera Wang | Kenmark Optical Co., Inc. | 849 |
| Disney | FGX International Inc. | 825 |
Showing 12 of 1,317. All products under Sunglasses (Non-Prescription Including Photosensitive)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K913419 | 1992-02-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.