(78 days)
Not Found
No
The document describes a standard examination glove and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is an examination glove, which is a barrier to prevent contamination, not a treatment.
No
Explanation: The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner." Its function is barrier protection, not diagnosis based on physical examination, imaging, or laboratory tests.
No
The device is a physical examination glove, which is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to be worn on the hand or finger of an examiner to prevent contamination. It does not involve the analysis of any biological samples.
- The description focuses on the physical properties and barrier function of the glove. The testing mentioned (dimensions, physical properties, pinholes, powder residue, biocompatibility, chemotherapy drug permeation) are all related to the glove's performance as a barrier and its safety for the user and patient. These are not tests performed on patient specimens to diagnose or monitor a condition.
- The device is a physical barrier. IVDs are typically reagents, instruments, or systems used to perform tests on samples.
The information provided clearly describes a medical device intended for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is a disposable device intended for medical purpose that is worn on the examiner 's hand to prevent contamination between patient and examiner.
The chemotherapy drugs tested are as follows: Amethopterin Hydrate (Methotrexate), Cisplatin, Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), 5-Fluorouracil, Paclitaxel (Taxol), and Vincristine Sulfate.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Non sterile, Powder free Nitrile Examination Glove, Lavender Blue with Polymer coated, Tested for use with chemotherapy drugs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance test data of the non-clinical tests that support a determination of substantial equivalence.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 6319-00a-05 | Meets |
| Physical Properties | ASTM D 6319-00a-05 | Meets |
| Freedom from pinholes | ASTM D 6319-00a-05 | Meets |
| Powder Free Residue | ASTM D 6319-00a-05 | Meets |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passes |
| Guinea Pig Sensitization | Passes | |
| Permeation by Chemotherapy Drugs (ASTM D6978-05) | - | Passes for all chemicals as below : 1.Amethopterin Hydrate (Methotrexate) 2.Cisplatin 3.Cyclophosphamide (Cytoxan) 4.Dacarbazine (DTIC) 5.Doxorubicin Hydrochloride 6.Etoposide (Toposar) 7.5-Fluorouracil 8.Paclitaxel (Taxol) 9. Vincristine Sulfate |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
510 (k) Summary
MAR 5 2009
As Required by 21 section 807.92 (c)
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- Submitter Name: Siam Sempermed Corp., Ltd
110 Kanjanavanit Road. Pahtong Hatyai 2. Address: Songkhla. Thailand 90230
- Submitter Name: Siam Sempermed Corp., Ltd
-
(466) 74 291 648 3. Phone:
-
(466) 74 291 650 4. Fax:
-
న్. Contract Person: Mrs. Sureerat Choosri (Product Manager)
-
Date summary prepared: December 01,2008 6.
-
- Official Correspondent: Sempermed USA Inc.
13900 49th Street North 8. Address: Clearwater, USA , FL 33762
-
- Phone: 727 787 7250
- 727 787 7558 10. Fax:
- Mr. William E. Harris 11. Contact person:
-
- Device Trade or Proprietary Name: Non sterile, Powder free Nitrile Examination Glove, Lavender Blue with Polymer coated, Tested for use with chemotherapy drugs.
-
- Device Common or usual name: Examination glove
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- Device Classification Name: Nitrile Patient Examination Glove (Powder Free(Polymer coated),Lavender Blue color).
15. Description of the Device:
Non sterile, Powder free Nitrile Examination Glove, Lavender Blue with Polymer coated, Tested for use with chemotherapy drugs.
16. Intended use of the device:
This device is a disposable device intended for medical purpose that is worn on the examiner 's hand to prevent contamination between patient and examiner.
The chemotherapy drugs tested are as follows: Amethopterin Hydrate (Methotrexate), Cisplatin, Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), 5-Fluorouracil, Paclitaxel (Taxol), and Vincristine Sulfate.
17. Summary of The Technological Characteristics of The devices:
Non sterile, Powder free Nitrile Examination Glove, Lavender Blue with Polymer coated, Tested for use with chemotherapy drugs are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 6319-00a-05 | Meets |
| Physical Properties | ASTM D 6319-00a-05 | Meets |
| Freedom from pinholes | ASTM D 6319-00a-05 | Meets |
| Powder Free Residue | ASTM D 6319-00a-05 | Meets |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passes |
| Guinea Pig Sensitization | Passes |
1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Permeation by Chemotherapy | ||
| Drugs (ASTM D6978-05) | - | Passes for all chemicals as below : |
| 1.Amethopterin Hydrate (Methotrexate) | ||
| 2.Cisplatin | ||
| 3.Cyclophosphamide (Cytoxan) | ||
| 4.Dacarbazine (DTIC) | ||
| 5.Doxorubicin Hydrochloride | ||
| 6.Etoposide (Toposar) | ||
| 7.5-Fluorouracil | ||
| 8.Paclitaxel (Taxol) |
- Vincristine Sulfate |
18. Substantial Equivalents Based on Assessment of Non-Clinical Performance Data
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
19. Conclusion
It can be concluded that the Non sterile, Powder free Nitrile Examination Glove, Lavender Blue with Polymer coated, Tested for use with chemotherapy drugs will perform according to the glove performance standards referenced in section 17 above and meet ASTM standards, and FDA requirements. Consequently, this device is substantially equivalent to currently marketed device is safe and effective as the predicate device Siam Sempermed Nitrile, Examination Glove, Blue, Powder free(Polymer coated) ,Tested for use with chemotherapy drugs. Indeed, it is equivalent. This is better expressed in the tabulated comparison as below.
Technical comparison of specific elements is attached in the main submission.
| FDA file reference number | 510k number: K080520 |
|---|---|
| Attachments inside notification submission file | REFER TO APPENDIX 1 |
| TECHNOLOGICAL | |
| CHARACTERISTICS | Comparison result |
| REFER TO ADDITIONAL TECHNICAL | |
| COMPARATIVE TABLE WITHIN 510K | |
| SUBMISSION | |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Identical |
| Sterility | Identical (Not applicable) |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical (Not applicable) |
| Compatibility with environment and | |
| other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is stylized and composed of curved lines.
5 2009 MAR
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siam Sempermed Corporation, Limited C/o Mr. William E. Harris President & CEO Sempermed USA, Incorporated 13900 49th Street North Clearwater, Florida 33762
Re: K083755
Trade/Device Name: Non-Sterile, Powder-Free Nitrile Examination Glove, Lavender Blue with Polymer Coating, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.2650 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: February 12, 2009 Received: February 13, 2009
Dear Mr. Harris:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Harris
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Anthony D. Watson ba
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): KO83755
Device Name: Non-Sterile, Powder-Free Nitrile Examination Glove, Lavender Blue with Polymer Coating, Tested for Use With Chemotherapy Drugs
Indications For Use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs are as follows: Amethopterin Hydrate (Methotrexate), Cisplatin, Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), 5-Fluorouracil, Paclitaxel (Taxol), and Vincristine Sulfate.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Shule H. M. Mynhey, M.D.
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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