Officespec
Single-Sided Vaginal Speculum With Light Single-USE Size Medium
40manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Jiangsu (15), Zhejiang (15), Shanghai (5). 6 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 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Linhai Deyi Plastic Co., Ltd. | Linhai | Zhejiang | Contract manufacturer | 15 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
Showing 12 of 40. All 40 manufacturers in China registered for Speculum, Vaginal, Nonmetal
Record
| Listed by | OBP Medical Corporation, United States |
|---|---|
| FDA product code | HIB |
| Device type | Speculum, Vaginal, Nonmetal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K091937 |
| Record published | 2016-09-22 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment humidity 45 to 85 % RH; Handling environment temperature 5 to 35 °C |
| Packaging | Case of 4, box of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C020001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 30 |
| Vagispec Kolplast | Kolplast C I | 19 |
| EOS | North EOS Industries, Inc. | 19 |
| Shengbo | Yuhuan City Shengbo Mould Manufacturing Co., Ltd. | 18 |
| Centurion | Centurion Medical Products Corporation | 13 |
| ClearSpec | Clearspec, LLC | 12 |
| Speculux | Evexar Medical Limited | 12 |
| McKesson. | Mckesson Medical-Surgical Inc. | 11 |
| Instraspec | Robinson Healthcare Limited | 10 |
| PremierPro | Prestige Ameritech | 9 |
| Bioseal Inc. | Bioseal | 9 |
| ER-Spec/Office-Spec | OBP Medical Corporation | 6 |
Showing 12 of 75. All products under Speculum, Vaginal, Nonmetal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091937 | 2009-09-09 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| OBP Medical Corporation | 510(k) number | 2026-07-13 | Class II | Process control | There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider. | 8,224 boxes (148,032 units) |
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.