Puritan
Sterile Foam Tipped Applicators Swab used in 25-1506 1PFB SLD 20103 under 39017
100manufacturers in China registered for this device type
68catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (24), Zhejiang (20), Guangdong (12). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Bandex Industrial Corp. | Zhuhai | Guangdong | Contract manufacturer | 14 |
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Anqing Jiaxin Medical Technology Co., Ltd. | Anqing | Anhui | Contract manufacturer | 11 |
| Yancheng Huida Medical Instruments Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 10 |
| Changzhou Hongtai Paper Film Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
Showing 12 of 100. All 100 manufacturers in China registered for Applicator, Absorbent Tipped, Sterile
Record
| Listed by | Puritan Medical Products Company LLC, United States |
|---|---|
| FDA product code | KXG |
| Device type | Applicator, Absorbent Tipped, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6025 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2026-07-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, box of 100, box of 50, case of 1000, case of 5, case of 4 |
| Distribution end date | 2026-07-22 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 25-806 1PR | In distribution | ||
| 25-800 R 50 | In distribution | ||
| 25-806 2PR | In distribution | ||
| 25-806 1PDB SLD ABON | In distribution | ||
| 25-800 1PD 50 | In distribution | ||
| 25-1516 1PF SOLID CELLMARK | In distribution | ||
| 25-1805 1PF RND FDNA | In distribution | ||
| 25-806 1PC | In distribution | ||
| 25-800 1PD ALUM 50 | In distribution | ||
| 25-806 1PC BT | In distribution | ||
| 25-1616 1PF | In distribution | ||
| 25-1506 1PF BT | In distribution | ||
| 25-806 1PDS BINAX | In distribution | ||
| 25-1506 1PF TT MC | 100 | In distribution | |
| 25-826 2WD | In distribution | ||
| 25-1506 1PF 100 | In distribution | ||
| 25-800 D 50 | In distribution | ||
| 25-806 2WC | In distribution | ||
| 25-808 2PR | In distribution | ||
| 25-803 2WC | In distribution | ||
| 25-1506 1PFB SLD 20 | In distribution | ||
| 25-826 5WC | In distribution | ||
| 25-1506 1PF BT BL | In distribution | ||
| 25-806 1WC FDNA | In distribution | ||
| 25-3306-H BT | In distribution | ||
| 25-1805 1PF RND | In distribution | ||
| 25-806 1PR BT | In distribution | ||
| 25-1506 1PFB SMO SC 79MM | In distribution | ||
| 25-806 1PRB 250/10 UNB | In distribution | ||
| 25-1506 1PFB | In distribution | ||
| 25-806 2PC | In distribution | ||
| 25-806 1PD 7.5 | In distribution | ||
| 25-806 1PD SC 2 1/2 | In distribution | ||
| 25-806 1PRB 80/30 | In distribution | ||
| 25-806 2PC BLUE | In distribution | ||
| 25-806 1PDB UNBRK | In distribution | ||
| 25-806 2PR BT | In distribution | ||
| 25-806 10WC | In distribution | ||
| 25-806 2PD | In distribution | ||
| 25-806 1WC BT | In distribution | ||
| 25-806 1WC | In distribution | ||
| 25-1406 1PF 50 | In distribution | ||
| 25-808 1PR | In distribution | ||
| 25-806 1PD | In distribution | ||
| 25-806 1PDB PK002078J | In distribution | ||
| 25-1607 1PF SC | In distribution | ||
| 25-806 2PD TT | 60 | In distribution | |
| 25-803 2PC | In distribution | ||
| 25-1506 1PF SOLID | In distribution | ||
| 25-806 1PD SOLID | In distribution | ||
| 25-1406 1PFB | In distribution | ||
| 25-806 1WC 7.5 | In distribution | ||
| 25-1506 1PF DM | In distribution | ||
| 25-1503 1PFB SOLID | In distribution | ||
| 25-806 1WD | In distribution | ||
| 25-800 2PDBG | Withdrawn | ||
| 25-806 2WD | Withdrawn | ||
| 25-1000 1PD | Withdrawn | ||
| 25-806 1PDB 1500 | Withdrawn | ||
| 25-806 1PRLB | Withdrawn | ||
| 25-806 1WR | Withdrawn | ||
| 25-806 1PDS SC | Withdrawn | ||
| 25-1406 1PF TT MC 50 | Withdrawn | ||
| 25-805 1PR | Withdrawn | ||
| 25-800 2PDB | Withdrawn | ||
| 25-1597 10PF | Withdrawn | ||
| 25-806 2PD SC 3.875 | Withdrawn | ||
| 25-1406 1PF BT | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HanHeng | Jiangsu Hanheng Medical Technology Co., Ltd. | 188 |
| Custom Healthcare Systems Inc. | Manus Medical, LLC | 70 |
| FLOQSwabs® | Copan Italia | 54 |
| Puritan HydraFlock | Puritan Medical Products Company LLC | 39 |
| Specimen Collection Swab | HLB Co., Ltd. Healthcare | 38 |
| DeRoyal | Deroyal Industries, Inc. | 31 |
| Puritan PurFlock Ultra | Puritan Medical Products Company LLC | 29 |
| iClean | Huachenyang(Shenzhen)Technology Co., Ltd. | 28 |
| DHI Specimen Collection System | Diagnostic Hybrids, Inc. | 27 |
| National Hospital Packaging | Surgi-Pak, Inc. | 27 |
| Dryswab | Medical Wire & Equipment Company (Bath), Ltd. | 26 |
| CLASSIQSwabs™ | Copan Italia | 22 |
Showing 12 of 134. All products under Applicator, Absorbent Tipped, Sterile
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-02-21 | Class II | Process control | It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contained product code 25-3317-U in all packages. | 465 boxes x 500 units per box = 232,500 units | |
| 2014-12-22 | Class II | Process control | Shaft breaks so that adequate patient specimen sample cannot be obtained. | 9 cases of 500 applicators each | 2015-03-18 |
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.