(199 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier protection of examination gloves, with no mention of AI or ML technologies.
No.
The device functions as a barrier to prevent contamination, not to treat a condition or disease.
No
The device is a patient examination glove, which is described as providing 'single use barrier protection for the wearer' and is for 'prevent[ing] contamination between patient and examiner'. This function is protective, not diagnostic.
No
The device is a physical examination glove made of nitrile, clearly described as a hardware product for barrier protection.
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 fingers to prevent contamination between patient and examiner." This describes a barrier device used externally on the body.
- Device Description: The description reinforces this, calling it a "patient examination glove" made from nitrile.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a patient's health. This device does not perform any such analysis or testing of specimens.
- Regulatory Classification: The device is classified as Class I under 21 CFR 880.6250, which is the regulation for patient examination gloves, not IVD devices.
- Performance Studies: The performance studies focus on physical properties, barrier protection, and resistance to chemotherapy drugs, all of which are relevant to a protective glove, not an IVD.
In summary, the device functions as a physical barrier during patient examination and does not perform any diagnostic testing on biological specimens.
N/A
Intended Use / Indications for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs:
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min) |
|---|---|
| 1. Carmustine (BCNU), 3.3 mg/ml | 6.2 |
| 2. Thiotepa, 10.0 mg/ml | 38.8 |
| 3. Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| 4. Cisplatin, 1.0 mg/ml | ≥ 240 |
| 5. Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| 6. Fluorouracil, 50.0 mg/ml | ≥ 240 |
| 7. Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| 8. Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| 9. Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permention time: Carmustine (BCNU), 3.3 mg/ml 6.2 minutes Thiotepa, 10.0 mg/ml 38.8 minutes
Disposable Powder Free Nitrile Examination Glove, White Color, Tested For Use With Chemotherapy Drugs:
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min) |
|---|---|
| 1. Carmustine (BCNU), 3.3 mg/ml | 22.8 |
| 2. Thiotepa, 10.0 mg/ml | 54.6 |
| 3. Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| 4. Cisplatin, 1.0 mg/ml | ≥ 240 |
| 5. Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| 6. Fluorouracil, 50.0 mg/ml | ≥ 240 |
| 7. Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| 8. Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| 9. Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: Carmustine (BCNU), 3.3 mg/ml 22.8 minutes Thiotepa, 10.0 mg/ml 54.6 minutes
Product codes
LZA, LZC
Device Description
Disposable Powder Free Nitrile Examination Glove, White/Blue Color, Tested For Use With Chemotherapy Drugs is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or fingers of the examiner.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical professional).
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 performance data was summarized, demonstrating the subject devices met acceptance criteria for various tests.
Key results from non-clinical testing:
- Dimension: Complies with ASTM D6319-10(Reapproved 2015) for Length (≥220mm), Width (Small 80 ±10 mm, Medium 95 ±10 mm, Large 110 ±10 mm, X large 120 ±10 mm), and Thickness (Finger tip ≥0.05mm, Palm ≥0.05mm).
- Physical Properties: Complies with ASTM D6319-10(Reapproved 2015) for Tensile strength (Before aging ≥14MPa, After aging ≥14MPa) and Elongated rate (Before aging ≥500%, After aging ≥400%).
- Freedom from pinholes: Passed 21 CFR 800.20 Standard Acceptance Criteria.
- Powder Residual: Complies with ASTM D6319-10(Reapproved 2015) and test methods in accordance with ASTM D5151-06(Reapproved 2015) and D6124-06(Reaffirmation 2011) (
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2019
Ever Global (Vietnam) Enterprise Corporation % Albert T.w. Li Official Third Party Correspondent Center For Measurement Standards Of Industrial Bldg. 16, 321 Kuang Fu Rd,sec2 Hsinchu, Tw
Re: K190403
Trade/Device Name: Disposable Powder Free Nitrile Examination Glove, White Color, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drug Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I Product Code: LZA, LZC Dated: August 27, 2019 Received: September 3, 2019
Dear Albert T.w. Li:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
No. 1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam
Tel: 84-61-3514022
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K190403
Device Name
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time ( Min) |
|---|---|
| 1. Carmustine (BCNU), 3.3 mg/ml | 6.2 |
| 2. Thiotepa, 10.0 mg/ml | 38.8 |
| 3. Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| 4. Cisplatin, 1.0 mg/ml | ≥ 240 |
| 5. Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| 6. Fluorouracil, 50.0 mg/ml | ≥ 240 |
| 7. Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| 8. Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| 9. Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permention time: Carmustine (BCNU), 3.3 mg/ml 6.2 minutes Thiotepa, 10.0 mg/ml 38.8 minutes
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
3
No. 1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam
Tel: 84-61-3514022
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Disposable Powder Free Nitrile Examination Glove, White Color, Tested For Use With Chemotherapy Drugs
Indications for Use (Describe)
A patient exammation gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time ( Min) |
|---|---|
| 1. Carmustine (BCNU), 3.3 mg/ml | 22.8 |
| 2. Thiotepa, 10.0 mg/ml | 54.6 |
| 3. Cyclophosphamide (Cytoxan), 20.0 mg/ml | $\geq$ 240 |
| 4. Cisplatin, 1.0 mg/ml | $\geq$ 240 |
| 5. Doxorubicin Hydrochloride, 2.0 mg/ml | $\geq$ 240 |
| 6. Fluorouracil, 50.0 mg/ml | $\geq$ 240 |
| 7. Dacarbazine (DTIC), 10.0 mg/ml | $\geq$ 240 |
| 8. Etoposide (Toposar), 20.0 mg/ml | $\geq$ 240 |
| 9. Paclitaxel (Taxol), 6.0 mg/ml | $\geq$ 240 |
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: Carmustine (BCNU), 3.3 mg/ml 22.8 minutes Thiotepa, 10.0 mg/ml 54.6 minutes
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
4
No. 1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam
Tel: 84-61-3514022
| 510(k) SUMMARY | |
|---|---|
| K190403 | |
| Premarket Notification [510(k)] Summary | |
| 1.0 Submitter: | |
| Submitter's name : | Ever Global (Vietnam) Enterprise Corporation |
| Submitter's address : | No. 1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District, |
| Dong Nai Province, Vietnam | |
| Phone number : | 84-61-3514022 |
| Fax number : | 84 -61-3514023 |
| Name of contact person: | Jerry Lin |
| Summary Preparation Date: | September 6, 2019 |
| 2.0 Name of the Device | |
| Proprietary/Trade name: | Disposable Powder Free Nitrile Examination Glove, White Color, Tested For |
| Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination | |
| Glove, Blue Color, Tested For Use With Chemotherapy Drugs | |
| Common Name: | Nitrile Examination Gloves |
| Classification Name: | Patient Examination Glove |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 880.6250 |
| Product Code: | LZA, LZC |
| 3.0 Predicate device | |
| Device Name: | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for |
| Use with Chemotherapy Drugs (Blue, Black) | |
| Company name: | Koon Seng Sdn. Bhd. |
| 510(K) Number: | K171171 |
| 4.0 Device Description: | |
| Disposable Powder Free Nitrile Examination Glove, White/Blue Color, Tested For Use With Chemotherapy Drugs is a | |
| patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle | |
| operation of the medical device to provide single use barrier protection for the wearer and the device meets all the | |
| requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification |
for Nitrile Examination Gloves.
5.0 Indication for use:
Disposable Powder Free Nitrile Examination Glove, White Color, Tested For Use With Chemotherapy Drugs
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min.) | |
|---|---|---|
| 1. | Carmustine (BCNU), 3.3 mg/ml | 22.8 |
| 2. | Thiotepa, 10.0 mg/ml | 54.6 |
| 3. | Cyclophosphamide (Cytoxan), 20.0 mg/ml | 2 240 |
| 4. | Cisplatin, 1.0 mg/ml | 2 240 |
| 5. | Doxorubicin Hydrochloride, 2.0 mg/ml | 2 240 |
| 6. | Fluorouracil, 50.0 mg/ml | 2 240 |
| 7. | Dacarbazine (DTIC), 10.0 mg/ml | 2 240 |
| 8. | Etoposide (Toposar), 20.0 mg/ml | 2 240 |
| 9. | Paclitaxel (Taxol), 6.0 mg/ml | 2 240 |
Table 5.1 Nitrile white color test for 9 chemotherapy drugs
5
No. 1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam
Tel: 84-61-3514022
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
| Table 5.2 Nitrile blue color test for 9 chemotherapy drugs | ||
|---|---|---|
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min.) | |
| 1. | Carmustine (BCNU), 3.3 mg/ml | 6.2 |
| 2. | Thiotepa, 10.0 mg/ml | 38.8 |
| 3. | Cyclophosphamide (Cytoxan), 20.0 mg/ml | 2 240 |
| 4. | Dacarbazine (DTIC), 10.0 mg/ml | 2 240 |
| 5. | Doxorubicin Hydrochloride, 2.0 mg/ml | 2 240 |
| 6. | Etoposide (Toposar), 20.0 mg/ml | 2 240 |
| 7. | Fluorouracil, 50.0 mg/ml | 2 240 |
| 8. | Paclitaxel (Taxol), 6.0 mg/ml | 2 240 |
| 9. | Cisplatin, 1.0 mg/ml | 2 240 |
Table 5 2 Nitrile blue color test for 9 chemotherapy drugs
6.0 Technological Characteristics:
Shown below is a technological comparison of the subject device(K190403) with the predicate device (K171171)
| Device
| Characteristic | Predicate Device (K171171) | Proposed Device (K190403) | Comparison |
|---|---|---|---|
| Product name | KS Medicare Powder Free Nitrile | ||
| Examination Gloves, Non-sterile, Tested for | |||
| Use with Chemotherapy Drugs (Blue, Black) | Disposable Powder Free Nitrile Examination | ||
| Glove, White/Blue Color, Tested For Use With | |||
| Chemotherapy Drugs | N/A | ||
| 510(K) No. | K171171 | K171422 | N/A |
| Product Owner | Koon Seng Sdn. Bhd. | Ever Global Enterprise Corporation | Different |
| Product Code | LZA, LZC | LZA, LZC | same |
| Regulation | 21 CFR 880.6250 | 21 CFR 880.6250 | same |
| Class | I | I | same |
| Intended Use | A powder-free 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. | |||
| In addition, these gloves were tested for use | |||
| with chemotherapy drugs in accordance | |||
| with ASTM D6978-05 Standard Practice for | |||
| Assessment of Medical gloves to Permeation | |||
| by Chemotherapy Drugs: | The Nitrile Powder Free patient examination | ||
| glove is a non-sterile disposable device | |||
| intended for medical purposes that is worn on | |||
| the examiner's hands or finger to prevent | |||
| contamination between patient and examiner. | |||
| In addition, these gloves were tested for use | |||
| with chemotherapy drugs in accordance with | |||
| ASTM D6978-05 Standard Practice for | |||
| Assessment of Medical gloves to Permeation | |||
| by Chemotherapy Drugs: | similar | ||
| Power free | Yes | Yes | same |
| Size | Small/ Medium/Large/X Large | Small/ Medium/Large/X Large | same |
| Single Use | YES | YES | same |
| Non-Sterile | YES | YES | same |
| Dimensions- | |||
| Length | Complies with ASTM D6319-10 | ||
| 230 mm min | Complies with ASTM D6319-10 | ||
| 230 mm min | same | ||
| Dimensions | |||
| -Palm Width | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | same |
| Small | |||
| $80\pm10$ | Small | ||
| $80\pm10$ | |||
| Medium | |||
| $95 \pm10$ | Medium | ||
| $95 \pm10$ | |||
| Large | |||
| $110\pm10$ | Large | ||
| $110\pm10$ | |||
| X large | |||
| $120 \pm10$ | X large | ||
| $120 \pm10$ | |||
| Dimensions | |||
| -Thickness | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | |
| Palm - | |||
| 0.07 mm min. | Palm - 0.05mm min. | similar | |
| Finger - | |||
| 0.08 mm min. | Finger - 0.05 mm min. | ||
| {Additional comparisons a device - K171104, | |||
| that have been approved by FDA is the same | |||
| intended use and the thickness is lower than | |||
| Proposed Device) | |||
| Intended Use | A powder-free patient examination glove is | The Nitrile Powder Free patient examination | similar |
| a disposable device intended for medical | glove is a non-sterile disposable device | ||
| purposes that is worn on the examiner's | intended for medical purposes that is worn on | ||
| hand or finger to prevent contamination | the examiner's hands or finger to prevent | ||
| between patient and examiner. | contamination between patient and examiner. | ||
| In addition, these gloves were tested for use | In addition, these gloves were tested for use | ||
| with chemotherapy drugs in accordance | with chemotherapy drugs in accordance with | ||
| with ASTM D6978-05 Standard Practice for | ASTM D6978-05 Standard Practice for | ||
| Assessment of Medical gloves to Permeation | Assessment of Medical gloves to Permeation | ||
| by Chemotherapy Drugs: | by Chemotherapy Drugs: | ||
| Power free | Yes | Yes | same |
| Size | Small/ Medium/Large/X Large | Small/ Medium/Large/X Large | same |
| Single Use | YES | YES | same |
| Non-Sterile | YES | YES | same |
| Dimensions- | |||
| Length | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | same |
| 230 mm min. | 230 mm min. | ||
| Dimensions | |||
| -Palm Width | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | same |
| Small | |||
| $80\pm10$ | Small | ||
| $80\pm10$ | |||
| Medium | |||
| $95 \pm10$ | Medium | ||
| $95 \pm10$ | |||
| Large | |||
| $110\pm10$ | Large | ||
| $110\pm10$ | |||
| X large | |||
| $120 \pm10$ | X large | ||
| $120 \pm10$ | |||
| Dimensions | |||
| -Thickness | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | |
| Palm - | |||
| 0.07 mm min. | Palm - 0.05mm min. | similar | |
| Finger - | |||
| 0.08 mm min. | Finger - 0.05 mm min. | ||
| {Additional comparisons a device - K171104, | |||
| that have been approved by FDA is the same | |||
| intended use and the thickness is lower than | |||
| Proposed Device) | |||
| Biocompatibility | Primary Skin Irritation in rabbits ISO 10993-10 | ||
| Dermal sensitization in the guinea pig ISO | |||
| 10993-10 / | Primary Skin Irritation in rabbits ISO 10993-10: | ||
| Third Edition 2010-08-01 | |||
| Dermal sensitization in the guinea pig ISO 10993- | |||
| 10: Third Edition 2010-08-01 | |||
| Minimal Essential Media (MEM) Elution | |||
| ISO 10993-5 | similar | ||
6
No. 1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam Tel: 84-61-3514022
7.0 Summary of Non-Clinical Performance Data:
Shown below are the results from the bench testing performed on the subject devices. The testing was performed to
7
No. 1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam
Tel: 84-61-3514022
demonstrate the subject devices met the acceptance criteria for each of the non-clinical test shown below: Disposable Powder Free Nitrile Examination Glove, White/Blue Color, Tested For Use With Chemotherapy Drugs are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Table 7.1 Summary of the Non-Clinical Testing | |
|---|---|
| Characteristics | Standard |
| Dimension | ASTM standard D 6319-10(Reapproved 2015) |
| Length 2230mm | |
| Width | |
| Small 80 ±10 mm | |
| Medium 95 ±10 mm | |
| Large 110 ±10 mm | |
| X large 120 ±10 mm | |
| Thickness | |
| Finger tip 20.05mm | |
| Palm 20.05mm | |
| Physical Properties | ASTM standard D 6319-10(Reapproved 2015) |
| Tensile strength (Before aging) 214MPa | |
| Tensile strength (After aging) 214MPa | |
| Elongated rate (Before aging) 2500% | |
| Elongated rate (After aging) 2400% | |
| Freedom from pinholes | 21 CFR 800.20 Passed Standard Acceptance Criteria |
| Powder Residual | ASTM standard D 6319-10(Reapproved 2015) |
| Test method in accordance with ASTM D5151-06(Reapproved 2015) Acceptance Criteria | |
| ASTM standard D6319-10(Reapproved 2015) | |
| Test method in accordance with D6124-06(Reaffirmation 2011) |