(13 days)
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a single-use, powder-free, non-sterile device.
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Carboxylated Nitrile. These gloves are blue in color and are powder free. The product is non-sterile, textured, ambidextrous with beaded cuff and single use only. Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) with sizes X-Small, Small, Medium, Large, X-Large and XX-Large are included in the submission.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for "Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)":
1. A table of acceptance criteria and the reported device performance
| Characteristic / Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions (ASTM D6319-19) | ||
| Length | X-Small: 220 mm min; Small: 220 mm min; Medium: 230 mm min; Large: 230 mm min; X-Large: 230 mm min; XX-Large: 230 mm min | X-Small: 270 mm; Small: 273 mm; Medium: 274 mm; Large: 276 mm; X-Large: 278 mm; XX-Large: 276 mm |
| Width | X-Small: 70+/-10 mm; Small: 80+/-10 mm; Medium: 95+/-10 mm; Large: 110+/-10 mm; X-Large: 120+/-10 mm; XX-Large: 130+/-10 mm | X-Small: 72 mm; Small: 82 mm; Medium: 97 mm; Large: 103 mm; X-Large: 112 mm; XX-Large: 126 mm |
| Thickness | Palm: 0.05 mm min for all sizes; Finger: 0.05 mm min for all sizes | Palm: 0.12 mm for all sizes; Finger: 0.14 mm for all sizes |
| Physical Properties (ASTM D6319-19) | ||
| Tensile Strength (Before Ageing) | 14 MPa min for all sizes | X-Small: 17.7 MPa; Small: 18.1 MPa; Medium: 18.3 MPa; Large: 18.4 MPa; X-Large: 18.2 MPa; XX-Large: 18.5 MPa |
| Tensile Strength (After Ageing) | 14 MPa min for all sizes | X-Small: 16.8 MPa; Small: 17.3 MPa; Medium: 17.2 MPa; Large: 17.6 MPa; X-Large: 17.5 MPa; XX-Large: 17.6 MPa |
| Ultimate Elongation (Before Ageing) | 500% min for all sizes | X-Small: 637%; Small: 634%; Medium: 647%; Large: 630%; X-Large: 644%; XX-Large: 644% |
| Ultimate Elongation (After Ageing) | 400% min for all sizes | X-Small: 532%; Small: 539%; Medium: 542%; Large: 536%; X-Large: 529%; XX-Large: 533% |
| Freedom from Holes (ASTM D5151-19) | AQL 2.5 | Gloves Passes AQL 2.5 |
| Residual Powder (ASTM D6124-06) | $\leq$ 2 mg/glove | X-Small: 0.21 mg/glove; Small: 0.18 mg/glove; Medium: 0.18 mg/glove; Large: 0.19 mg/glove; X-Large: 0.21 mg/glove; XX-Large: 0.20 mg/glove |
| Chemotherapy Drug Permeation (ASTM D6978-05 (2019)) | ||
| Carboplatin (10mg/ml) | > 240 Minutes | > 240 Minutes |
| Carmustine (3.3mg/ml) | Not specified as an acceptance criterion value, but rather a reported breakthrough time leading to a warning. No specific "pass/fail" for this drug against a threshold is listed. | 15.9 Minutes |
| Cisplatin (1mg/ml) | > 240 Minutes | > 240 Minutes |
| Cyclophosphamide (20mg/ml) | > 240 Minutes | > 240 Minutes |
| Cytarabine HCl (100mg/ml) | > 240 Minutes | > 240 Minutes |
| Dacarbazine (10mg/ml) | > 240 Minutes | > 240 Minutes |
| Docetaxel (10mg/ml) | > 240 Minutes | > 240 Minutes |
| Doxorubicin HCl (2mg/ml) | > 240 Minutes | > 240 Minutes |
| Etoposide (20mg/ml) | > 240 Minutes | > 240 Minutes |
| Fluorouracil (50mg/ml) | > 240 Minutes | > 240 Minutes |
| Gemcitabine (38mg/ml) | > 240 Minutes | > 240 Minutes |
| Ifosfamide (50mg/ml) | > 240 Minutes | > 240 Minutes |
| Irinotecan (20mg/ml) | > 240 Minutes | > 240 Minutes |
| Mechlorethamine HCl (1mg/ml) | > 240 Minutes | > 240 Minutes |
| Melphalan (5mg/ml) | > 240 Minutes | > 240 Minutes |
| Methotrexate (25mg/ml) | > 240 Minutes | > 240 Minutes |
| Mitoxantrone (2mg/ml) | > 240 Minutes | > 240 Minutes |
| Paclitaxel (6mg/ml) | > 240 Minutes | > 240 Minutes |
| Thiotepa (10mg/ml) | Not specified as an acceptance criterion value, but rather a reported breakthrough time leading to a warning. No specific "pass/fail" for this drug against a threshold is listed. | 54.2 Minutes |
| Biocompatibility (ISO 10993 Series) | ||
| Primary Skin Irritation (ISO 10993-23) | Under the condition of study not an irritant | Under the condition of study, not an irritant |
| Dermal Sensitization (ISO 10993-10) | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| In Vitro Cytotoxicity (ISO 10993-5) | Under the conditions of the study, non-cytotoxic | Under the conditions of the study, non-cytotoxic |
| Acute Systemic Toxicity (ISO 10993-11) | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of the study, the test item did not produce any adverse effect |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each test. For many of the physical and chemical property tests (e.g., dimensions, tensile strength, freedom from holes, residual powder, chemotherapy drug permeation), the relevant ASTM standards (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D6978-05) would specify the required statistical sampling plans, but the summary document only provides the results.
Similarly, for biocompatibility tests (ISO 10993 series), the number of animals or cell cultures used is not detailed in this summary, but the standards themselves outline the required protocols.
The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. Given that these are bench and lab tests for a premarket notification, it's highly probable that the tests were conducted prospectively by the manufacturer or a contracted testing laboratory to demonstrate compliance with the referenced standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided since the studies performed are bench testing and biocompatibility testing against established international standards (ASTM and ISO). These types of tests do not typically involve human experts establishing a "ground truth" through interpretation, as would be the case for an AI diagnostic device. Instead, the "ground truth" is defined by the objective measurement parameters and criteria specified in the standard test methods themselves.
4. Adjudication method for the test set
Not applicable. As noted above, these are objective bench and lab tests against predefined specifications in standards. There is no subjective interpretation requiring an adjudication method like 2+1 or 3+1. The results are quantitative measurements or direct observations (e.g., passes/fails AQL).
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
Not applicable. This device is a medical glove, not an AI diagnostic device. Therefore, no MRMC study involving human readers or AI assistance was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical glove, not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the performance evaluation of these nitrile examination gloves are the acceptance criteria defined by the relevant ASTM and ISO standards. These standards provide:
- Specific measurable thresholds (e.g., minimum length, minimum tensile strength, maximum residual powder).
- Defined test methods and methodologies (e.g., how to measure breakthrough time for chemotherapy drugs, how to assess irritation or sensitization).
- Statistical sampling plans (e.g., AQL for freedom from holes).
Compliance with these pre-defined, objective criteria from the standards constitutes the "ground truth" for the device's performance.
8. The sample size for the training set
Not applicable. This is a physical device (medical glove), not an AI model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
October 26, 2022
PT. Sintong Unigolden Glove % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K223235
Trade/Device Name: Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ Dated: October 19, 2022 Received: October 19, 2022
Dear Manoj Zacharias:
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/cfpmn/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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
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 mediation-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.
Bifeng Qian, M.D., Ph.D. Assistant Director 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}------------------------------------------------
Indications for Use
510(k) Number (if known) K223235
Device Name
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
Indications for Use (Describe)
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with cherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a single-use, powderfree, non-sterile device.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carboplatin | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 15.9 Minutes |
| Cisplatin | 1 mg/ml (1,000 ppm) | > 240 Minutes |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Cytarabine HCl | 100 mg/ml (100,000 ppm) | > 240 Minutes |
| Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Docetaxel | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Doxorubicin HCl | 2 mg/ml (2,000 ppm) | > 240 Minutes |
| Etoposide | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50 mg/ml (50,000 ppm) | > 240 Minutes |
| Gemcitabine | 38 mg/ml (38,000 ppm) | > 240 Minutes |
| Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 Minutes |
| Irinotecan | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | > 240 Minutes |
| Melphalan | 5 mg/ml (5,000 ppm) | > 240 Minutes |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 Minutes |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | > 240 Minutes |
| Paclitaxel | 6 mg/ml (6,000 ppm) | > 240 Minutes |
| Thiotepa | 10 mg/ml (10,000 ppm) | 54.2 Minutes |
Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 15.9 Minutes Thiotepa 10 mg/m1 54.2 Minutes
Warning: Please do not use with Carmustine and Thiotepa.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{3}------------------------------------------------
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."
{4}------------------------------------------------
A. APPLICANT INFORMATION
| 510(K) Owner's Name | PT. Sintong Unigolden Glove |
|---|---|
| Address | Jl. Lintas Sumatera, Kel. Hessa Perlompongan,Kec. Air Batu, Kab. Asahan, Kota Kisaran,Sumatera Utara, Indonesia 21272 |
| Phone | +62623533339 |
| Fax | +62623533330 |
| sug.qualityassurance@gmail.com | |
| Contact Person | Vivekanandan |
| Designation | Production Manager |
| Contact Number | +681253206449 |
| Contact Email | vivekmp80@gmail.com |
| Date Submitted | 13 October 2022 |
B. DEVICE IDENTIFICATION
| Name of the device | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) |
|---|---|
| Product proprietary or trade name | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) |
| Common or usual name | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) |
| Classification name | Patient Examination Glove, Specialty |
| Device Classification | Class-1 |
| Product Code | LZA, LZC, OPJ |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | Nitrile Patient Examination Gloves Blue ColoredTested For Use With Chemotherapy Drugs |
|---|---|
| 510(k) Number | K213040 |
| Regulatory Class | Class 1 |
| Product code | LZA, LZC, OPJ |
| Reference Device | Non-Sterile Nitrile Powder Free ExaminationGloves - Blue, Green and Black color |
|---|---|
| 510(k) Number | K210388 |
| Regulatory Class | Class 1 |
| Product code | LZA |
{5}------------------------------------------------
D. DESCRIPTION OF THE DEVICE:
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Carboxylated Nitrile. These gloves are blue in color and are powder free. The product is non-sterile, textured, ambidextrous with beaded cuff and single use only.
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) with sizes X-Small, Small, Medium, Large, X-Large and XX-Large are included in the submission.
E. INDICATION FOR USE OF THE DEVICE:
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a single-use, powder-free, non-sterile device.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carboplatin | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 15.9 Minutes |
| Cisplatin | 1 mg/ml (1,000 ppm) | > 240 Minutes |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Cytarabine HCl | 100 mg/ml (100,000 ppm) | > 240 Minutes |
| Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Docetaxel | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Doxorubicin HCl | 2 mg/ml (2,000 ppm) | > 240 Minutes |
| Etoposide | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50 mg/ml (50,000 ppm) | > 240 Minutes |
| Gemcitabine | 38 mg/ml (38,000 ppm) | > 240 Minutes |
| Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 Minutes |
| Irinotecan | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | > 240 Minutes |
| Melphalan | 5 mg/ml (5,000 ppm) | > 240 Minutes |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 Minutes |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | > 240 Minutes |
| Paclitaxel | 6 mg/ml (6,000 ppm) | > 240 Minutes |
| Thiotepa | 10 mg/ml (10,000 ppm) | 54.2 Minutes |
The tested chemotherapy drugs and their breakthrough detection times are as follows:
{6}------------------------------------------------
Please note that the following drugs have low permeation times: Carmustine (3.3 mg/ml) 15.9 Minutes Thiotepa (10 mg/ml) 54.2 Minutes Warning: Do not use with Carmustine & Thiotepa
F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | |||
| 510(K) Number | --- | K213040 | K210388 | K223235 | |
| Name of device | --- | Nitrile PatientExamination GlovesBlue Colored TestedFor Use WithChemotherapy Drugs | Non SterileNitrilePowder FreeExaminationGloves –Blue, GreenAnd Blackcolor | Nitrile ExaminationGloves Powder Free(Tested for use withChemotherapy Drugs) | Similartopredicatedevice |
| Product Code | --- | LZA, LZC, OPJ | LZA | LZA, LZC, OPJ | Similar topredicatedevice |
| Indication for use | --- | The blue colored nitrileexamination glove isintended to be worn onthe hands of examiner'sto preventcontaminationbetween patient andexaminer. This is asingle-use, powder-free,non-sterile device.The Nitrile PatientExamination GlovesBlue Colored weretested for use withchemotherapy drugs perASTM D6978-05(Reapproved 2019)Standard Practice forAssessment of MedicalGloves to Permeationby ChemotherapyDrugs. | A powderfree patientexaminationglove is adisposabledeviceintended formedicalpurposes thatis worn ontheexaminer'shand orfinger topreventcontamination betweenpatient andexaminer. | Nitrile ExaminationGloves Powder Free(Tested for use withChemotherapy Drugs) isa disposable deviceintended for medicalpurpose that is worn onthe examiner's hand toprevent contaminationbetween patient andexaminer. In addition,these gloves were testedfor use withchemotherapy drugs inaccordance with ASTMD6978-05 (2019)Standard Practice forAssessment ofResistance of MedicalGloves to Permeationby ChemotherapyDrugs. This is a single-use, powder-free, non-sterile device. | Similar topredicatedevice |
| Regulation Number | --- | 21 CFR 880.6250 | 21 CFR880.6250 | 21 CFR 880.6250 | Same |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
| PREDICATE | REFERENCE | SUBJECT | |||
| 510(K) Number | --- | K213040 | K210388 | K223235 | |
| Material | Powder-Free Nitrile | CarboxylatedButadieneAcrylonitrile asbase material | Carboxylated NitrileRubber | Same as thereferencedevice | |
| Color | --- | Blue | Blue, Green andBlack | Blue | Same aspredicatedevice |
| Size | --- | X-Small, Small,Medium, Large, X-Large andXX-Large | Small, Medium,Large andX-Large | X-Small, Small,Medium, Large, X-Large andXX-Large | Same aspredicatedevice |
| Single Use | --- | Single Use | Single Use | Single Use | Same |
| Sterile/non sterile | --- | non sterile | non sterile | non sterile | Same |
| Rx Only or OTC | --- | Over the Counter | Over theCounter | Over the Counter | Same |
| Dimensions - Length | ASTMD6319-19 | XS (220mm min)S (220mm min)M (230mm min)L (230mm min)XL (230mm min)XXL (230mm min) | 240-246 mm(Medium) | XS (220mm min)S (220mm min)M (230mm min)L (230mm min)XL (230mm min)XXL (230mm min) | Same aspredicatedeviceSize AveragevalueX- Small 270Small 273Medium 274Large 276X-Large 278XX-Large 276 |
| Dimensions - Width | ASTMD6319-19 | XS (70±10mm)S (80±10mm)M (95±10mm)L(110±10mm)XL (120±10mm)XXL (≥120mm) | 95-98 mm(Medium) | XS (70±10mm)S (80±10mm)M (95±10mm)L(110±10mm)XL (120±10mm)XXL (130±10mm) | SimilarSize AveragevalueX-Small 72Small 82Medium 97Large 103X-Large 112XX-Large 126 |
{7}------------------------------------------------
{8}------------------------------------------------
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | |||||||||||||||||
| 510(K) Number | --- | K213040 | K210388 | K223235 | |||||||||||||||
| Physical Properties-Tensile Strength | ASTM D6319-2019 | Before AgeingTensile Strength≥14MPa, min | Before AgeingTensile Strength25.9-32.0 MPa(Medium) | Before AgeingTensile Strength14MPa, min | Similar | ||||||||||||||
| Size Average value X-Small 17.7 Small 18.1 Medium 18.3 Large 18.4 X-Large 18.2 XX-Large 18.5 | |||||||||||||||||||
| After AgeingTensile Strength≥14MPa, min | After AgeingTensile Strength25.4-34.0 MPa(Medium) | After AgeingTensile Strength14MPa, min | Similar | ||||||||||||||||
| Size Average value X-Small 16.8 Small 17.3 Medium 17.2 Large 17.6 X-Large 17.5 XX-Large 17.6 | |||||||||||||||||||
| Physical Properties-Ultimate Elongation | ASTM D6319-2019 | Before AgeingUltimateElongation500% min | Before AgeingUltimateElongation500-540 %(Medium) | Before AgeingUltimate Elongation500% min | Same aspredicatedevice | ||||||||||||||
| Size Average value X-Small 637 Small 634 Medium 647 Large 630 X-Large 644 XX-Large 644 | |||||||||||||||||||
| After AgeingUltimateElongation400% min | After AgeingUltimateElongation480-520 %(Medium) | After AgeingUltimate Elongation400% min | Same aspredicatedevice | ||||||||||||||||
| Size Average value X-Small 532 Small 539 Medium 542 Large 536 X-Large 529 XX-Large 533 |
{9}------------------------------------------------
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | ||||||||||||||||||||||||
| 510(K) Number | K213040 | K210388 | K223235 | |||||||||||||||||||||||
| Thickness | ASTMD6319-19 | Palm0.05mm min | Palm0.06-0.06 mm(Medium) | Palm 0.05 mm min;Finger 0.05 mm min | Similar | |||||||||||||||||||||
| Finger0.11 mm min | Finger0.09-0.10 mm(Medium) | Size Palm(Avg value) Finger(Avg value) X-Small 0.12 0.14 Small 0.12 0.14 Medium 0.12 0.14 Large 0.12 0.14 X-Large 0.12 0.14 XX-Large 0.12 0.14 | ||||||||||||||||||||||||
| Powder Free Residue | ASTM D6319-19 | <2mg per glove | 0.70mg/glove(Medium) | ≤2 mg/glove Size Average value X-Small 0.21 Small 0.18 Medium 0.18 Large 0.19 X-Large 0.21 XX-Large 0.20 | Similar | |||||||||||||||||||||
| Freedom from holes | ASTM D5151-2019 | Complies with ASTMD6319-19 and ASTMD5151-19 G-1,AQL 1.5 | InspectionLevel G-1;AQL=2.5 | Complies with ASTMD6319-19 and ASTMD5151-19 G-1, AQL 2.5 | Same asreferencedevice | |||||||||||||||||||||
| Chemotherapy DrugsTested with MinimumBreakthroughDetection Time | ASTM D6978-05 (2019) | Bleomycin Sulfate15 mg/ml >240 min.Carboplatin 10 mg/ml>240 min.Carmustine (BCNU)3.3 mg/ml 17.2 min.Cisplatin 1.0 mg/ml>240 min.Cyclophosphamide(Cytoxan)20.0 mg/ml >240 min.Cytarabine HCl100 mg/ml >240 min.Dacarbazine (DTIC)10.0 mg/ml >240 min.Daunorubicin5.0 mg/ml >240 min.Docetaxel 10.0 mg/ml>240 min | NA | Not testedCarboplatin 10 mg/ml(10,000 ppm) > 240 MinutesCarmustine 3.3 mg/ml(3,300 ppm) 15.9 MinutesCisplatin 1 mg/ml(1,000 ppm) > 240 MinutesCyclophosphamide 20 mg/ml(20,000 ppm) > 240 MinutesCytarabine HCl100 mg/ml (100,000 ppm)>240 MinutesDacarbazine 10 mg/ml(10,000 ppm) > 240 MinutesNot testedDocetaxel 10 mg/ml(10,000 ppm) >240 Minutes | Optional*SameSimilarSameSameSameSameOptional*Same |
{10}------------------------------------------------
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | |||
| 510(K) Number | K213040 | K210388 | K223235 | ||
| Chemotherapy DrugsTested with MinimumBreakthroughDetection Time | ASTMD6978-05(2019) | Doxorubicin HCl2.0 mg/ml >240 min. | NA | Doxorubicin HCl 2 mg/ml(2,000 ppm) > 240 Minutes | Same |
| Etoposide (Toposar)20.0 mg/ml >240 min. | NA | Etoposide 20 mg/ml(20,000 ppm) > 240 Minutes | Same | ||
| Fluorouracil50.0 mg/ml >240 min. | NA | Fluorouracil 50 mg/ml(50,000 ppm) > 240 Minutes | Same | ||
| Gemcitabine38 mg/ml >240 min. | NA | Gemcitabine 38 mg/ml(38,000 ppm) >240 Minutes | Same | ||
| Idarubicin 1 mg/ml>240 min. | NA | Not tested | Optional* | ||
| Ifosfamide 50.0 mg/ml>240 min. | NA | Ifosfamide 50 mg/ml(50,000 ppm) >240 Minutes | Same | ||
| Irinotecan 20.0 mg/ml>240 min. | NA | Irinotecan 20 mg/ml(20,000 ppm) >240 Minutes | Same | ||
| Mechlorethamine HCl1.0 mg/ml >240 min. | NA | Mechlorethamine HCl1 mg/ml (1,000 ppm)>240 Minutes | Same | ||
| Melphalan 5 mg/ml>240 min. | NA | Melphalan 5 mg/ml(5,000 ppm) >240 Minutes | Same | ||
| Methotrexate25 mg/ml >240 min. | NA | Methotrexate 25 mg/ml(25,000 ppm) >240 Minutes | Same | ||
| Mitromycin C.0.5 mg/ml >240 min. | NA | Not tested | Optional* | ||
| Mitoxantrone2.0 mg/ml >240 min. | NA | Mitoxantrone 2 mg/ml(2,000ppm) > 240 Minutes | Same | ||
| Paclitaxel (Taxol)6.0 mg/ml >240 min. | NA | Paclitaxel 6 mg/ml(6,000 ppm) > 240 Minutes | Same | ||
| Thiotepa 10.0 mg/ml13.9 min. | NA | Thiotepa 10 mg/ml(10,000 ppm) 54.2 Minutes | Similar | ||
| Vincristine Sulfate1.0 mg/ml >240 min. | NA | Not tested | Optional* | ||
| Contact Durations | --- | Limited <24 hours | NA | Limited <24 hours | Same |
| Biocompatibility | Primary SkinIrritation- ISO10993-23:First Edition2021-01 | Not a skin irritant | Non-irritant(ResponseCategory isNegligible) | Under the condition of studynot an irritant | Same |
| DermalSensitization-ISO 10993-10:Fourth Edition2021-11 | Not a skin sensitizer | Non-sensitizer(Nosensitization) | Under the conditions of thestudy not a sensitizer | Same | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
| PREDICATE | REFERENCE | SUBJECT | |||
| 510(K) Number | --- | K213040 | K210388 | K223235 | |
| Biocompatibility | In vitrocytotoxicity-ISO 10993-5:Third Edition2009-06-01 | At the neat extraction,the test article isconsidered cytotoxic | --- | Under the conditionsof the study, non-cytotoxic | Different** |
| AcuteSystemicToxicity- ISO10993-11:Third Edition2017-09 | The acute systemictoxicity resultsdemonstrate thedevicewill not cause asystemiceffect. | Notoxic effects | Under the conditionsof the study, the testitem did not produceany adverse effect | Same |
{11}------------------------------------------------
- Predicate device perform additional Chemotherapy drug test.
** The difference does not raise any issue regarding the safety or effectiveness of the subject glove is non-cytotoxic.
There are no significant differences between the products other than In vitro cytotoxicity study and are identical in terms of intended use, materials, design and manufacturing methods. The devices meet the ASTM standard D6319-19 and D6978-05 (2019).
G. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA
BENCH TEST DATA
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT |
|---|---|---|---|
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thelength of the gloves | X-Small : 220 mm minSmall : 220 mm minMedium: 230 mm minLarge : 230 mm minX-Large: 230 mm minXX-Large: 230 mm min | X-Small : 270 mmSmall : 273 mmMedium : 274 mmLarge : 276 mmX-Large : 278 mmXX-Large : 276 mm |
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thewidth of the gloves | X-Small : 70+/-10 mmSmall : 80+/-10 mmMedium: 95+/-10 mmLarge: 110+/-10 mmX-Large: 120+/-10 mmXX-Large: 130+/-10 mm | X-Small : 72 mmSmall : 82 mmMedium : 97 mmLarge : 103 mmX-Large : 112 mmXX-Large : 126 mm |
{12}------------------------------------------------
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thethickness of thegloves | Palm: 0.05 mm minfor all sizesFinger: 0.05 mm minfor all sizes | Size Palm Finger X-Small 0.12 mm 0.14 mm Small 0.12 mm 0.14 mm Medium 0.12 mm 0.14 mm Large 0.12 mm 0.14 mm X-Large 0.12 mm 0.14 mm XX-Large 0.12 mm 0.14 mm | |||||||||||||||||||||
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thephysical properties-Tensile strength | Before AgeingTensile Strength14MPa min for all sizesAfter AgeingTensile Strength14MPa min for all sizes | Size Beforeageing Afterageing X-Small 17.7 MPa 16.8 MPa Small 18.1 MPa 17.3 MPa Medium 18.3 MPa 17.2 MPa Large 18.4 MPa 17.6 MPa X-Large 18.2 MPa 17.5 MPa XX-Large 18.5 MPa 17.6 MPa | |||||||||||||||||||||
| To determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500% min for all sizesAfter AgeingUltimate Elongation400% min for all sizes | Size Beforeageing Afterageing X-Small 637% 532% Small 634% 539% Medium 647% 542% Large 630% 536% X-Large 644% 529% XX-Large 644% 533% | ||||||||||||||||||||||
| ASTM D5151-19 StandardTest Method for Detectionof Holes in Medical Gloves | To determine theholes in the gloves | AQL 2.5 | Gloves Passes AQL 2.5 | |||||||||||||||||||||
| ASTM D6124-06(Reapproved 2017) StandardTest Method for ResidualPowder on Medical Gloves | To determine theresidual powder inthe gloves | $≤$ 2 mg/glove | X-Small : 0.21 mg/gloveSmall : 0.18 mg/gloveMedium : 0.18 mg/gloveLarge : 0.19 mg/gloveX-Large : 0.21 mg/gloveXX-Large : 0.20 mg/glove |
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT |
|---|---|---|---|
| ASTM D6978-05(Reapproved 2019)Standard Practice forAssessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs. | To determine thebreakthroughdetection time ofchemotherapydrugs | Carboplatin 10 mg/ml(10,000 ppm) > 240 Minutes | Carboplatin 10 mg/ml(10,000 ppm) > 240 Minutes |
| Cisplatin 1 mg/ml(1,000 ppm) > 240 Minutes | Cisplatin 1 mg/ml(1,000 ppm) > 240 Minutes | ||
| Cyclophosphamide 20 mg/ml(20,000 ppm) > 240 Minutes | Cyclophosphamide 20 mg/ml(20,000 ppm) > 240 Minutes | ||
| Cytarabine HCl 100 mg/ml(100,000 ppm) >240 Minutes | Cytarabine HCl 100 mg/ml(100,000 ppm) >240 Minutes | ||
| Dacarbazine 10 mg/ml(10,000 ppm) > 240 Minutes | Dacarbazine 10 mg/ml(10,000 ppm) > 240 Minutes | ||
| Docetaxel 10 mg/ml(10,000 ppm) > 240 Minutes | Docetaxel 10 mg/ml(10,000 ppm) > 240 Minutes |
{13}------------------------------------------------
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT |
|---|---|---|---|
| ASTM D6978-05(Reapproved 2019)Standard Practice forAssessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs. | To determine thebreakthroughdetection time ofchemotherapydrugs | Doxorubicin HCl 2 mg/ml(2,000 ppm) > 240 MinutesEtoposide 20 mg/ml(20,000 ppm) > 240 MinutesFluorouracil 50 mg/ml(50,000 ppm) > 240 MinutesGemcitabine 38 mg/ml(38,000 ppm) >240 MinutesIfosfamide 50 mg/ml(50,000 ppm) >240 MinutesIrinotecan 20 mg/ml(20,000 ppm) >240 MinutesMechlorethamine HCl 1 mg/ml(1,000 ppm) > 240 MinutesMelphalan 5 mg/ml(5,000 ppm) > 240 MinutesMethotrexate 25 mg/ml(25,000 ppm) >240 MinutesMitoxantrone 2 mg/ml(2,000ppm) > 240 MinutesPaclitaxel 6 mg/ml(6,000 ppm) > 240 Minutes | Doxorubicin HCl 2 mg/ml(2,000 ppm) > 240 MinutesEtoposide 20 mg/ml(20,000 ppm) > 240 MinutesFluorouracil 50 mg/ml(50,000 ppm) > 240 MinutesGemcitabine 38 mg/ml(38,000 ppm) >240 MinutesIfosfamide 50 mg/ml(50,000 ppm) >240 MinutesIrinotecan 20 mg/ml(20,000 ppm) >240 MinutesMechlorethamine HCl 1 mg/ml(1,000 ppm) >240 MinutesMelphalan 5 mg/ml(5,000 ppm) >240 MinutesMethotrexate 25 mg/ml(25,000 ppm) >240 MinutesMitoxantrone 2 mg/ml(2,000ppm) > 240 MinutesPaclitaxel 6 mg/ml(6,000 ppm) > 240 Minutes |
BIOCOMPATIBILITY DATA
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT |
|---|---|---|---|
| ISO 10993-23 First edition2021-01 BiologicalEvaluation of MedicalDevices - Part 23, Tests forIrritation. | To evaluate the test item, forskin irritation test in NewZealand White rabbits. | Under the conditionof study not anirritant | Under the condition ofstudy, not an irritant |
| 10993-10 Fourth edition2021-11 BiologicalEvaluation of MedicalDevices - Part 10, Tests forSkin Sensitization. | To evaluate the test item, forthe skin sensitization in Guineapigs by maximization test. | Under the conditionsof the study, not asensitizer | Under the conditions ofthe study, not a sensitizer |
| ISO 10993-5 Third edition2009-06-01 BiologicalEvaluation of MedicalDevices - Part 5, Tests for InVitro Cytotoxicity. | To evaluate the test item, for itsability to induce cytotoxicityusing L-929 mouse fibroblastcells by Elution Method. | Under the conditionsof the study, non-cytotoxic | Under the conditions ofthe study, non-cytotoxic |
| ISO 10993-11 Third edition2017-09 BiologicalEvaluation of MedicalDevices - Part 11, Tests forSystemic Toxicity. | To evaluate the test item, foracute systemic toxicity inSprague Dawley Rats. | Under the conditionsof study, the deviceextracts do not pose asystemic toxicityconcern | Under the conditions ofthe study, the test item didnot produce any adverseeffect |
{14}------------------------------------------------
The performance test data of the non-clinical tests that support a determination of safety and equivalence is the same as mentioned above (ASTM Requirements).
The performance test data of the non-clinical tests meet following standards:
ASTM D6319-19 Standard Specification for Nitrile examination Gloves for Medical Application.
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves.
ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
ISO 10993-23 First Edition 2021-01 Biological Evaluation of Medical Devices - Part 23, Tests for Irritation.
ISO 10993-10 Fourth Edition 2021-11 Biological Evaluation of Medical Devices - Part 10, Tests for Skin Sensitization.
ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation of Medical Devices - Part 5, Tests for In Vitro Cytotoxicity.
ISO 10993-11 Third Edition 2017-09 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity.
H. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves.
I. CONCLUSION
The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(K) submission, Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K213040.
§ 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.