(224 days)
A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.
The provided text describes the acceptance criteria and performance of "Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs." This is a medical device, and the data presented relates to its physical and chemical properties, not an AI/ML powered device. Therefore, many of the requested fields are not applicable.
Here's the information extracted from the document based on the prompt:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Standards | Acceptance Criteria (Predicate) | Reported Device Performance (Current) |
|---|---|---|---|
| Manufacturer | - | Kossan International Sdn Bhd | Maxter Gloves Manufacturing Sdn Bhd |
| 510 (K) Number | - | K151750 | K172864 |
| Dimensions | ASTM D6319-10 | ≥ 230mm | ≥ 230mm |
| Physical Properties | ASTM D6319-10 | Meet | Meet |
| Thickness - Finger - Palm | ASTM D6319-10 | ≥ 0.05mm | ≥ 0.05mm |
| Freedom From Holes | ASTM D6319-10 and ASTM D5151 | Pass | Pass |
| Powder Free Residue | ASTM D6319-10 and ASTM D6124 | Meet | Meet |
| Resistance to Permeation by Chemotherapy Drugs (ASTM D6978-05) | |||
| Carmustine (BCNU) 3.3mg/ml | Concentration | 10.1 minutes | 8.3 minutes |
| Cisplatin 1.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Cyclophosphamide (Cytoxan) 20mg/ml | Concentration | >240 minutes | >240 minutes |
| Cytarabine 100mg/ml | Concentration | >240 minutes | >240 minutes |
| Dacarbazine (DTIC) 10.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Doxorubicin Hydrochloride 2.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Etoposide (Toposar) 20.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Fluorouracil 50.0 mg/ml | Concentration | Not explicitly stated for Predicate in table, but indicated as >240 for Current device. Given the "similar to predicate" statement, it's reasonable to infer a similar acceptance criteria. | >240 minutes |
| Ifosfamide 50.0 mg/ml | Concentration | >240 minutes | >240 minutes |
| Methotrexate 25mg/ml | Concentration | >240 minutes | >240 minutes |
| Mitomycin C 0.5mg/ml | Concentration | >240 minutes | >240 minutes |
| Mitoxantrone 2.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Paclitaxel (Taxol) 6.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Thiotepa 10.0mg/ml | Concentration | 30.2 minutes | 38.0 minutes |
| Vincristine Sulfate 1.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Warning Statement | - | Warning: Please note that the following drugs have extremely low permeation times: Carmustine(BCNU): 10.1 minutes and Thiotepa: 30.2 minutes | Warning: Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU): 8.3 minutes and Thiotepa: 38.0 minutes. Do not use with Carmustine or Thiotepa. |
| Biocompatibility: Primary Skin Irritation | ISO 10993 | Non-irritant | Non-irritant |
| Biocompatibility: Dermal Sensitization | ISO 10993 | Non-sensitizer | Non-sensitizer |
| Biocompatibility: In vitro Cytotoxicity | ISO 10993 | Not available (for Predicate) | The device extract was not cytotoxic. |
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Color | - | Blue, and white | Blue |
| Texture | - | Finger Textured | Finger Textured |
| Size | Medical Glove Guidance Manual-Labeling | Extra Small, Small, Medium, Large, Extra Large | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Glove Guidance Manual-Labeling | Single use | Single use |
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 sample size for the tests conducted to determine the breakthrough detection times or other physical properties. It generally refers to conducting tests "in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs," and other ASTM and ISO standards. These standards typically specify sample sizes for their respective tests. The provenance of the data is implied to be from the manufacturer's testing (Maxter Glove Manufacturing Sdn Bhd) in Malaysia, as they are the submitter of the 510(k). The tests are prospective in nature, as they are performed to demonstrate compliance with standards for the device being submitted.
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)
Not applicable. This is a physical device (gloves) and the "ground truth" is established through standardized laboratory testing against chemical permeation and physical properties, not through expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical device.
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 is a physical device, not an AI/ML powered medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements conducted according to established international and national standards (e.g., ASTM D6319-10, ASTM D5151, ASTM D6124, ASTM D6978-05, ISO 10993). This involves laboratory measurements for physical dimensions, tensile strength, elongation, freedom from holes, powder residue levels, breakthrough time for chemotherapy drugs, and biocompatibility endpoints (irritation, sensitization, cytotoxicity).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML-powered device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 2, 2018
Maxter Glove Manufacturing Sdn Bhd Yap Peak Geeh QA & Regulatory Affairs Manager Lot 6070, Jalan Haji Abdul Manah 6th Miles off Jalan Meru 41050 Klang, Selangor Malaysia
Re: K172864
Trade/Device Name: Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: March 30. 2018 Received: April 6, 2018
Dear Yap Peak Geeh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K.
Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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) K172864
R1/2001
Device Name
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU). 3.3mg/ml (3,300ppm) | 8.3 |
| Cisplatin. 1.0 mg/ml (1,000ppm) | >240 |
| Cyclophosphamide (Cytoxan). 20mg/ml (20,000ppm) | >240 |
| Cytarabine 100mg/ml (100,000ppm) | >240 |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 |
| Doxorubicin Hydrochloride. 2.0mg/ml (2,000ppm) | >240 |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 |
| Fluorouracil 50.0mg/ml (50,000ppm) | >240 |
| Ifosfamide. 50.0mg/ml (50,000ppm) | >240 |
| Methotrexate 25mg/ml (25,000ppm) | >240 |
| Mitomycin C. 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone 2.0mg/ml (2,000ppm) | >240 |
| Paclitaxel (Taxol). 6.0mg/ml (6,000ppm) | >240 |
| Thiotepa. 10.0mg/ml (10,000ppm) | 38.0 |
| Vincristine Sulfate 1.0mg/ml (1,000ppm) | >240 |
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510(K) SUMMARY
Date Prepared: 30th April 2018
1.0 Submitter:
| Name | : | Maxter Glove Manufacturing Sdn Bhd |
|---|---|---|
| Address | : | Lot 6070 Jalan Haji Abdul Manan,6th Miles off Jalan Meru,41050 Klang, Selangor, Malaysia. |
| Phone No. | : | 603-33929888 |
| Fax No. | : | 603-33923328 |
2.0 Name of the device:
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Common Name Patient Examination Gloves : Brand Name Maxter Classification Name: Polymer Patient Examination Glove (21 CFR 880.6250 Product Code LZA)
3.0 Identification Of The Legally Marketed Devices that equivalency is claimed:
| Predicate | |
|---|---|
| Manufacturer | Kossan International Sdn Bhd |
| Device Name | Powder Free Nitrile Patient ExaminationGlove, Blue Colored, Non-Sterile. Testedfor Use with Chemotherapy Drugs |
| 510(k) Number | K151750 |
| Regulation Number | 21 CFR 880.6250 |
| Regulatory Name | Patient Examination Glove |
| Regulatory Class | I |
Patient Examination Gloves Specialty (21 CFR 880.6250 Product Code LZC)
4.0 Description of the Device:
These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.
5.0 Indications for Use statement for the subject device:
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A Non-Sterile Powder Free Blue Nitrile Examination Glove Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05.
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU). 3.3mg/ml (3,300ppm) | 8.3 |
| Cisplatin. 1.0 mg/ml (1,000ppm) | >240 |
| Cyclophosphamide (Cytoxan). 20mg/ml (20,000ppm) | >240 |
| Cytarabine 100mg/ml (100,000ppm) | >240 |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 |
| Doxorubicin Hydrochloride. 2.0mg/ml (2,000ppm) | >240 |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 |
| Fluorouracil 50.0 mg/ml (50,000ppm) | >240 |
| Ifosfamide 50.0 mg/ml (50,000ppm) | >240 |
| Methotrexate 25mg/ml (25,000ppm) | >240 |
| Mitomycin C. 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone 2.0mg/ml (2,000ppm) | >240 |
| Paclitaxel (Taxol) 6.0mg/ml (6,000ppm) | >240 |
| Thiotepa 10.0mg/ml (10,000ppm) | 38 |
| Vincristine Sulfate 1.0mg/ml (1,000ppm) | >240 |
Please note that the following drugs have low permeation time of less than 240minutes: Carmustine (BCNU), 3.3mg/ml: 8.3 Minutes Thiotepa. 10.0mg/ml: 38.0 Minutes
6.0 Summary of the Technological Characteristics Comparison:
Below is the summary of the technological characteristics of the Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs compare to ASTM D6319 or equivalent standards. Chemotherapy claim is similar to predicate device, which has a glove thickness of minimum 0.05mm and is shorter than 270mm but in compliance with the ASTM standards.
| Characteristics | Standards | Device Performance | |
|---|---|---|---|
| Predicate | Current | ||
| Manufacturer | KossanInternational SdnBhd | Maxter GlovesManufacturing SdnBhd | |
| 510 (K) Number | K151750 | K172864 | |
| Dimensions | ASTM D6319-10 | $\geq$ 230mm | $\geq$ 230mm |
| Physical Properties | ASTM D6319-10 | Meet | Meet |
| Thickness- Finger-palm | ASTM D6319-10 | ≥ 0.05mm | ≥ 0.05mm |
| Freedom FromHoles | ASTM D6319-10and ASTM D5151 | Pass | Pass |
| Powder FreeResidue | ASTM D6319-10and ASTM D6124 | Meet | Meet |
| Resistance toPermeation byChemotherapyDrugs: | ASTM D6978-05 | ||
| Test ChemotherapyDrug | Concentration | Minimum Breakthrough Detection Time(min) | |
| Carmustine (BCNU) | 3.3mg/ml | 10.1 | 8.3 |
| Cisplatin | 1.0mg/ml | >240 | >240 |
| Cyclophosphamide(Cytoxan) | 20mg/ml | >240 | >240 |
| Cytarabine | 100mg/ml | >240 | >240 |
| Dacarbazine (DTIC) | 10.0mg/ml | >240 | >240 |
| DoxorubicinHydrochloride | 2.0mg/ml | >240 | >240 |
| Etoposide (Toposar) | 20.0mg/ml | >240 | >240 |
| Ifosfamide | 50.0 mg/ml | >240 | >240 |
| Methotrexate | 25mg/ml | >240 | >240 |
| Mitomycin C. | 0.5mg/ml | >240 | >240 |
| Mitoxantrone | 2.0mg/ml | >240 | >240 |
| Paclitaxel (Taxol) | 6.0mg/ml | >240 | >240 |
| Thiotepa | 10.0mg/ml | 30.2 | 38.0 |
| Vincristine Sulfate | 1.0mg/ml | >240 | >240 |
| Warning Statement | Warning: Please notethat the followingdrugs have extremelylow permeation times:Carmustine(BCNU):10.1 minutes andThiotepa: 30.2minutes | Warning : Pleasenote that thefollowing drugs havelow permeation timeof less than 240minutes: Carmustine(BCNU): 8.3minutes andThiotepa: 38.0minutes. Do not usewith Carmustine orThiotepa. | |
| Biocompatibility | Primary SkinIrritation-ISO 10993 | Under the conditionsof the study, this is anon-irritant. | Under the conditionsof the study, this is anon-irritant. |
| DermalSensitization-ISO10993 | Under the conditionsof the study, this is anon-sensitizer. | Under the conditionsof the study, this is anon-sensitizer. | |
| In vitro Cytotoxicity-ISO 10993 | Not available. | Under the conditionsof the study, thedevice extract wasnot cytotoxic. | |
| Intended Use | - | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand topreventcontaminationbetween patient andexaminer. Thesegloves were tested foruse withchemotherapy drugsper ASTM D6978-05(Reapproved 2013)Standard Practice forAssessment ofMedical Gloves toPermeation byChemotherapy Drugs. | Non-Sterile PowderFree Blue NitrileExamination GlovesTested for Use withChemotherapy Drugsis a disposabledevice intended formedical purposesthat is worn on theexaminer's handsand finger to preventcontaminationbetween patient andexaminer. Inaddition, thesegloves were testedfor use withchemotherapy drugsin accordance withASTMD6978-05. |
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Color | - | Blue, and white | Blue |
| Texture | - | Finger Textured | Finger Textured |
| Size | Medical GloveGuidance Manual-Labeling | Extra Small | Extra Small |
| Small | Small | ||
| Medium | Medium | ||
| Large | Large | ||
| Extra Large | Extra Large | ||
| Single Use | Medical GloveGuidance Manual-Labeling | Single use | Single use |
Table 1
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7.0 Summary of Non-Clinical Performance Data
The non-clinical performance test results for the subject device met the acceptance criteria in the standard or test method for dimension, physical properties, thickness,
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freedom from holes, powder residues, chemotherapy permeation, and biocompatibility testing.
8.0 Summary of Clinical Performance Data
Not applicable- clinical data is not needed for the intended use of this subject device.
9.0 Conclusion
Based on intended use, technological characteristics and non-clinical performance data, the Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is substantially equivalent to the predicate device K151750.
§ 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.