(69 days)
Not Found
No
The device is a patient examination glove, and the summary describes its physical properties, testing against standards, and resistance to chemotherapy drug permeation. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a patient examination glove, which is intended to prevent contamination between the patient and the examiner. It is not designed to treat or alleviate a disease or condition.
No
The device is a patient examination glove, which is a barrier device used to prevent contamination, not to diagnose a medical condition.
No
The device is a physical patient examination glove, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is classified as a "Polymer Patient Examination Glove" and meets standards related to physical properties, freedom from holes, and resistance to permeation. These are characteristics of a protective barrier, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The testing performed relates to the glove's barrier properties against chemotherapy drugs, which is a performance characteristic of the glove itself, not an in vitro diagnostic test.
Therefore, this device is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Chemotherapy Drug | Average BDT |
|---|---|
| Fluorouracil | >240 min. |
| Etoposide (Toposar) | >240 min. |
| Cyclophosphamide (Cytoxan) | >240 min. |
| Carmustine | 2.03 min. |
| Thiotepa | 25.23 min. |
| Paclitaxel (Taxol) | >240 min. |
| Doxorubicin Hydrochloride | >240 min. |
| Dacarbazine (DTIC) | >240 min. |
| Cisplatin | >240 min. |
| Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes. |
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
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)
Non-Clinical Tests Performed for Determination of Substantial Equivalence:
| Characteristics | Applicable Recognized Standards | FDA- | Performance Results |
|---|---|---|---|
| Dimensions | ASTM D 6319-00a (2005)e1 | Meets | |
| Physical Properties | ASTM D 6319-00a (2005)e1 | Meets | |
| Freedom from holes | Meets | ||
| Residual Powder Test | ASTM D 6319-00a (2005)e1 ASTM D6124-06 | Meets | |
| Primary Skin Irritation and Skin Sensitization | ISO 10993 Part 10 16CFR 1500.41 16CFR 1500.3 | Meets | |
| Resistance to Permeation | ASTM D6978-05 | See Data in Section 5 |
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
OCT 4 2010
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(K) number is: ___ K | 020 96
1. Submitter's Identification:
Mr. Xiaolin Shen Syntex Healthcare Products Co., Ltd No. 1 Fanjiazhuang Industrial, Zone, Xinji City, Hebei Province, China 052360 Tel: 86-311-83980319
Date Summary Prepared: June 7, 2010
2. Name of the Device:
Syntex Healthcare Products Co., Ltd Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)
3. Predicate Device Information:
Medline Industries Incorporated Mediguard Powder Free Nitrile Examination Glove (Blue)- Tested for use with Chemotherapy (K093726)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
5. Intended Use:
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Chemotherapy Drug | Average BDT |
|---|---|
| Fluorouracil | >240 min. |
| Etoposide (Toposar) | >240 min. |
| Cyclophosphamide (Cytoxan) | >240 min. |
| Carmustine | 2.03 min. |
| Thiotepa | 25.23 min. |
1
1
EXHIBIT #1 Page 2 of 3
| Paclitaxel (Taxol) | >240 min. |
|---|---|
| Doxorubicin Hydrochloride | >240 min. |
| Dacarbazine (DTIC) | >240 min. |
| Cisplatin | >240 min. |
Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes.
6. Comparison to Predicate Devices:
Syntex Healthcare Products Co., Ltd's Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs is substantially equivalent in safety and effectiveness to the Medline Industries, Incorporated's Mediguard Powder Free Nitrile Examination Glove (Blue)- Tested for use with Chemotherapy.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
| Characteristics | Applicable
Recognized Standards | FDA- | Performance Results |
|---------------------------------------------------|----------------------------------------------------|------|-----------------------|
| Dimensions | ASTM D 6319-00a
(2005)e1 | | Meets |
| Physical Properties | ASTM D 6319-00a
(2005)e1 | | Meets |
| Freedom from holes | | | Meets |
| Residual Powder Test | ASTM D 6319-00a
(2005)e1
ASTM D6124-06 | | Meets |
| Primary Skin Irritation
and Skin Sensitization | ISO 10993 Part 10
16CFR 1500.41
16CFR 1500.3 | | Meets |
| Resistance to Permeation | ASTM D6978-05 | | See Data in Section 5 |
8. Labeling:
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs with a chemotherapy claim, tested per ASTM D6978-05, and provide protection against: Fluorouracil, Etoposide (Toposar), Cyclophosphamide (Cytoxan), Paclitaxel (Taxol), Doxorubicin Hydrochloride, Dacarbazine (DTIC), Cisplatin. Do not use with Carmustine and Thiotepa. The tested chemotherapy drugs' breakthrough detection times, refer to item 5 in this summary for details.
We do not claim our gloves as hypoallergenic on our labels.
9. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
2
EXHIBIT #1 Page 3 of 3
10. Conclusions:
Syntex Healthcare Products Co., Ltd's Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs conform fully to ASTM D 6319-00a (2005)e1 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
Drawn from the complete list of non-clinical tests, the device is as safe and effective as the legally marketed predicate device K093726 Mediguard Powder Free Nitrile Examination Glove (Blue) Tested for Use with Chemotherapy Drugs.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Syntex Healthcare Products Company, Limited C/O Ms. Kathy Liu Surprotect Incorporated 3973 Schaefer Avenue Chino, California 91710
OCT 4 2010
Re: K102096
Trade/Device Name: Powder Free Nitrile Examination Glove, Tested for Use With Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Přoduct Code: LZA, LZC Dated: September 7, 2010 Received: September 8, 2010
Dear Ms. Liu:
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 from 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. Please note: CDRH, does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register.
4
Page 2- Ms. Liu
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 genies. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections S31-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket pntifics: 'on''' (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm1 for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment A
INDICATION FOR USE
K102096 510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
Syntex Healthcare Products Co., Ltd Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
INDICATIONS FOR USE:
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Chemotherapy Drug | Average BDT |
|---|---|
| Fluorouracil | >240 min. |
| Etoposide (Toposar) | >240 min. |
| Cyclophosphamide (Cytoxan) | >240 min. |
| Carmustine | 2.03 min. |
| Thiotepa | 25.23 min. |
| Paclitaxel (Taxol) | >240 min. |
| Doxorubicin Hydrochloride | >240 min. |
| Dacarbazine (DTIC) | >240 min. |
| Cisplatin | >240 min. |
Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter-Use _ (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
AND/ OR
Eslizlth F. (Laurete-Wilbs
Concurrent of CDRH, Office of Payiston Sigmeation (C (ORISSON Sigmation (ODE)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices
Division of Anesthesia, Dental Devices
Infection Control, Dental Devices
510(k) Number: K102096