(199 days)
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, 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.
The provided text is a 510(k) summary for Disposable Powder Free Nitrile Examination Gloves, white and blue colors, tested for use with chemotherapy drugs. It focuses on the safety and effectiveness of the device through non-clinical testing and comparison to a predicate device.
Here's an analysis to extract the requested information, noting that much of it pertains to AI/software device studies and is not applicable to this type of medical glove submission:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Standard / Acceptance Criteria | Reported Device Performance (White Gloves) | Reported Device Performance (Blue Gloves) |
|---|---|---|---|
| Chemotherapy Drug Permeation | ASTM D6978-05 Minimum Breakthrough Detection Time (Min) | ||
| Carmustine (BCNU), 3.3 mg/ml | - (No specific minimum listed, but tested) | 22.8 minutes | 6.2 minutes |
| Thiotepa, 10.0 mg/ml | - (No specific minimum listed, but tested) | 54.6 minutes | 38.8 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Cisplatin, 1.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Fluorouracil, 50.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Dimension | ASTM D6319-10(Reapproved 2015) | Complies | Complies |
| Length | ≥ 230mm | Complies (230 mm min) | Complies (230 mm min) |
| Width (Small) | 80 ±10 mm | Complies (80 ±10 mm) | Complies (80 ±10 mm) |
| Width (Medium) | 95 ±10 mm | Complies (95 ±10 mm) | Complies (95 ±10 mm) |
| Width (Large) | 110 ±10 mm | Complies (110 ±10 mm) | Complies (110 ±10 mm) |
| Width (X-Large) | 120 ±10 mm | Complies (120 ±10 mm) | Complies (120 ±10 mm) |
| Thickness (Finger tip) | ≥ 0.05mm | Complies (≥ 0.05mm) | Complies (≥ 0.05mm) |
| Thickness (Palm) | ≥ 0.05mm | Complies (≥ 0.05mm) | Complies (≥ 0.05mm) |
| Physical Properties | ASTM D6319-10(Reapproved 2015) | ||
| Tensile strength (Before aging) | ≥ 14MPa | Complies (≥ 14MPa) | Complies (≥ 14MPa) |
| Tensile strength (After aging) | ≥ 14MPa | Complies (≥ 14MPa) | Complies (≥ 14MPa) |
| Elongation (Before aging) | ≥ 500% | Complies (≥ 500%) | Complies (≥ 500%) |
| Elongation (After aging) | ≥ 400% | Complies (≥ 400%) | Complies (≥ 400%) |
| Freedom from pinholes | 21 CFR 800.20 and ASTM D6319-10 (Water leak test) | Passed | Passed |
| Powder Residual | ASTM D6319-10 (Test method D5151-06, D6124-06) Acceptance Criteria: < 2 mg/glove | Complies (< 2 mg/glove) | Complies (< 2 mg/glove) |
| Biocompatibility | ISO 10993-10 / ISO 10993-5 (Primary Skin Irritation, Dermal Sensitization, MEM Elution) | Passes (Not a primary skin irritant/sensitizer) | Passes (Not a primary skin irritant/sensitizer) |
Note: The document distinguishes between white and blue gloves for chemotherapy drug permeation times. For other characteristics, it states "White/Blue Color" and indicates compliance with the same standards, implying similar performance unless specified.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for permeation, pinholes, etc.). It refers to compliance with ASTM standards, which would define appropriate sample sizes for those tests.
- Data Provenance: The tests described are "bench testing" performed presumably by the manufacturer (Ever Global (Vietnam) Enterprise Corporation) or a contracted lab. The manufacturer's address is Vietnam. The testing standards are international (ASTM, ISO) and US federal regulations (21 CFR).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as this submission is for medical gloves and not a software/AI device that requires expert ground truth for interpretation. The "ground truth" for the performance criteria is defined by the objective measurements outlined in the referenced ASTM and ISO standards for physical properties, chemical resistance, and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as this is not a study involving subjective human interpretation requiring adjudication. Performance is measured against objective standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. This is a submission for a physical medical device (gloves), not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is a submission for a physical medical device (gloves), not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by objective measurements against recognized international and national standards:
- ASTM D6978-05: For chemotherapy drug permeation breakthrough times.
- ASTM D6319-10: For dimensions, physical properties (tensile strength, elongation), and freedom from pinholes (water leak test).
- 21 CFR 800.20: For freedom from pinholes.
- ASTM D5151-06 (Reapproved 2015) and D6124-06 (Reaffirmation 2011): For powder residual tests.
- ISO 10993-10: Third Edition 2010-08-01 and ISO 10993-5: For biocompatibility tests (primary skin irritation, dermal sensitization, MEM Elution).
8. The sample size for the training set
This question is not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This question is not applicable. There is no "training set" or need for "ground truth" establishment in the AI/ML sense for this device. The standards provide the criteria against which the device's physical and chemical properties are measured.
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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
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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
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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)
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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
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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 ForUse With Chemotherapy Drugs, Disposable Powder Free Nitrile ExaminationGlove, 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 forUse 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 apatient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principleoperation of the medical device to provide single use barrier protection for the wearer and the device meets all therequirement 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
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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)
| DeviceCharacteristic | Predicate Device (K171171) | Proposed Device (K190403) | Comparison |
|---|---|---|---|
| Product name | KS Medicare Powder Free NitrileExamination Gloves, Non-sterile, Tested forUse with Chemotherapy Drugs (Blue, Black) | Disposable Powder Free Nitrile ExaminationGlove, White/Blue Color, Tested For Use WithChemotherapy 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 isa disposable device intended for medicalpurposes that is worn on the examiner'shand or finger to prevent contaminationbetween patient and examiner.In addition, these gloves were tested for usewith chemotherapy drugs in accordancewith ASTM D6978-05 Standard Practice forAssessment of Medical gloves to Permeationby Chemotherapy Drugs: | The Nitrile Powder Free patient examinationglove is a non-sterile disposable deviceintended for medical purposes that is worn onthe examiner's hands or finger to preventcontamination between patient and examiner.In addition, these gloves were tested for usewith chemotherapy drugs in accordance withASTM D6978-05 Standard Practice forAssessment of Medical gloves to Permeationby 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 D6319-10230 mm min | Complies with ASTM D6319-10230 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 10993-10Dermal sensitization in the guinea pig ISO10993-10 / | Primary Skin Irritation in rabbits ISO 10993-10:Third Edition 2010-08-01Dermal sensitization in the guinea pig ISO 10993-10: Third Edition 2010-08-01Minimal Essential Media (MEM) ElutionISO 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 | |
| WidthSmall 80 ±10 mmMedium 95 ±10 mmLarge 110 ±10 mmX large 120 ±10 mm | |
| ThicknessFinger tip 20.05mmPalm 20.05mm | |
| Physical Properties | ASTM standard D 6319-10(Reapproved 2015)Tensile strength (Before aging) 214MPaTensile strength (After aging) 214MPaElongated 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) < 2 mg/glove | |
| Biocompatibility | Primary Skin Irritation in rabbitsISO 10993-10: Third Edition 2010-08-01 PassesUnder the conditions of the study, the subject device is not a primary skin irritant. |
| Dermal sensitization in the guinea pigISO 10993-10: Third Edition 2010-08-01 PassesUnder the conditions of the study, the subject device is not a primary skin sensitizer. | |
| Minimal Essential Media (MEM) ElutionISO 10993-5 PassesUnder the conditions of the study, the subject device is not a primary skin sensitizer. |
- な Dimension per ASTM D6319-10 (Reapproved 2015)
- な Tensile strength (Before aging) and Elongation (Before aging/After aging/After aging) per ASTM D6319-10(Reapproved 2015)
- భా Water leak test on pinhole per ASTM D6319-10(Reapproved 2015) and per 21 CFR 800.20.
- な Powder Residual tests per ASTM D6319-10(Reapproved 2015)
- な Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01 and ISO 10993-5
- な Assessment of Resistance To Permeation By Chemotherapy Drugs per ASTM D6978-05(R 2013)
8.0 Summary of Clinical Test:
Clinical data was not needed for this device.
9.0 Conclusion:
Based on the nonclinical tests data, it can be concluded that the Disposable Powder Free Nitrile Examination Glove, White/Blue Color, Tested For Use With Chemotherapy Drugs is as effective, and performs as well as or better than the predicate device K171171, KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black), by Koon Seng Sdn. Bhd.
§ 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.