(65 days)
A Powder Free Nitrile Patient Examination Glove is a dispoable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves are worn to protect against exposure to some chemotherapy drugs.
The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D 6319-00a83
The Perusahaan Getah Asas Sdn. Bhd. Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) demonstrates compliance with established acceptance criteria through a series of tests as detailed in the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00aε,3 | Meets |
| Physical Properties | ASTM D 412-98 | Meets |
| Freedom from pin-holes | ASTM D 5151-99 | Meets |
| Powder Free Residue | ASTM D 6124-01 | Meets |
| Biocompatibility (Dermal Sensitization) | Dermal Sensitization (as per ASTM F-720-81) | Not a contact skin sensitizer |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation Test (as per 16 CFR Part 1500) | Not a primary skin irritant |
| Biocompatibility (Cytotoxicity) | Cytotoxicity Test (as per ISO 10993-5) | Non cytotoxic |
| Low Dermatitis Potential | Modified Draize Test | Did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects. |
| Chemotherapy Drugs Permeation Test | ASTM F 739 (average normalized breakthrough time in minutes) | Carmustine (3.3 mg/mL): 137 min |
| Cisplatin (1.0 mg/mL): >240 min | ||
| Cyclophosphamide (20.0 mg/mL): >240 min | ||
| Dacarbazine (DTIC) (10.0 mg/mL): >240 min | ||
| Doxorubicin Hydrochloride (2.0 mg/mL): >240 min | ||
| 5-Fluorouracil (50.0 mg/mL): >240 min | ||
| Etoposide (20.0 mg/mL): >240 min | ||
| Paclitaxel (Taxol) (6.0 mg/mL): >240 min | ||
| Thio-Tepa (10.0 mg/mL): >240 min |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each individual test conducted to demonstrate device performance. However, the data provenance is implied to be from testing conducted by or for Perusahaan Getah Asas Sdn. Bhd., a company located in Malaysia. The studies are all retrospective in the sense that the data is presented post-hoc to demonstrate compliance with pre-defined standards. The data itself would have been generated through prospective experimental testing in a laboratory or clinical setting (e.g., the Modified Draize Test would involve human subjects in a prospective manner).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
For the most part, the "ground truth" for the performance tests (e.g., dimensions, physical properties, freedom from pin-holes, powder-free residue, chemotherapy drug permeation) is established by standardized laboratory methods and instrumentation, not by human expert consensus in the way a medical image interpretation might be. These are objective measurements against established ASTM and ISO standards.
For Biocompatibility tests (Dermal Sensitization, Primary Skin Irritation, Cytotoxicity, and the Modified Draize Test for Low Dermatitis Potential), experts would have been involved in the design, execution, and interpretation of these studies. However, the exact number and qualifications of these experts (e.g., toxicologists, dermatologists, clinical researchers) are not specified in the provided document. The Modified Draize test, by its nature, would typically involve at least one qualified dermatologist or clinician to assess skin reactions.
4. Adjudication Method for the Test Set:
For the physical and chemical property tests, adjudication is not typically applicable in the same way as for medical image interpretation or clinical trials involving subjective assessment. The results are generally objective measurements against established thresholds according to the given standards.
For the biocompatibility and low dermatitis potential tests, if multiple assessors were involved in evaluating skin reactions in the Modified Draize Test, their findings would likely be subject to an adjudication process to reach a consensus, but the document does not specify any adjudication method. It only states the conclusive finding ("Did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.").
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a patient examination glove, and its performance is evaluated through physical, mechanical, and biological properties, not through human interpretation of cases.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical product (a glove), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only) performance" does not apply. The device's performance is inherently "standalone" in the sense that it is measured directly without human-in-the-loop interpretation.
7. Type of Ground Truth Used:
The ground truth for most of the performance criteria (dimensions, physical properties, pin-holes, powder residue) is based on objective measurements against publicly recognized and established industry standards (ASTM, ISO, CFR).
For biocompatibility and low dermatitis potential, the ground truth is established through experimental results from standardized in-vitro and in-vivo tests designed to assess biological responses, with clinical observations (for the Modified Draize Test) serving as the ultimate verification of safety for skin contact.
8. Sample Size for the Training Set:
Not applicable. This device is a physical product, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development. The manufacturing process and quality control would involve ongoing testing, but this is not analogous to an AI training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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Attachment 4
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EC 1 € 2004 ERUSAHAAN GETAH ASAS SDN. BHD. (Company No: 89708-V)
Ammended Copy
FDA 510(k), Premarket Notification : 510(k) Summary of Safety and Effectiveness Information
1.0 Submitter:
Perusahaan Getah Asas Sdn Bhd Lot 1365, Batu 17, Jalan Sungai Sembilang, 45800 Jeram, Selangor Darul Ehsan, Malaysia
| Telephone No .: | +603 3264 0787 |
|---|---|
| Fax No .: | +603 3264 0644 |
2.0 Contact Person:
| Contact: | Mr Kong Chang TAN |
|---|---|
| Telephone No.: | +603 3291 1949 |
| Fax No.: | +603 3291 2903 |
3.0 Name of Device:
Trade Name: Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim)
Common Name: Patient Examination Glove Classification Name: Patient Examination Glove
4.0 Identification of The Legally Marketed Device:
The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim), Class I patient examination gloves, Nitrile-80LZC, meets all of the requirements, of ASTM D 6319-00a83 Standard Specification for Nitrile Examination Gloves for Medical Application.
5.0 Description of Device:
The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D 6319-00a83
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PERUSAHAAN GETAH ASAS SDN. BHD.
(Company No: 89708-V)
Ammended Copy
6.0 Intended Use of the Device:
The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The glove may provide additional protection in other areas where users are handling certain hazardous chemicals such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.
7.0 Summary of The Technological Characteristics of The Device:
The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) possesses the following technological characteristic (as compared to ASTM or equivalent standards):
| Characteristic | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00aε,3 | Meets |
| Physical Properties | ASTM D 412-98 | Meets |
| Freedom from pin-holes | ASTM D 5151-99 | Meets |
| Powder Free Residue | ASTM D 6124-01 | Meets |
| Biocompatibility | Dermal Sensitization(as per ASTM F-720-81) | Not a contact skin sensitizer |
| Primary Skin Irritation Test(as per 16 CFR Part 1500) | Not a primary skin irritant | |
| Cytotoxicity Test(as per ISO 10993-5) | Non cytotoxic | |
| Low DermatitisPotential | Modified Draize Test | Did not induce clinicallysignificant skin irritation norshow any evidence ofinduced allergic contactdermatitis in human subjects. |
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ERUSAHAAN GETAH ASAS SDN. BHD.
(Company No: 89708-V)
Ammended Copy
| Characteristic | Standards | Device Performance |
|---|---|---|
| Chemotherapy DrugsPermeation Test | ASTM F 739 | Chemotherapy Drug Permeation(average normalized breakthrough time inminutes) |
| Carmustine (3.3 mg/mL) 137 | ||
| Cisplatin (1.0 mg/mL) >240 | ||
| Cyclophosphamide (20.0 mg/mL) >240 | ||
| Dacarbazine (DTIC) (10.0 mg/mL) >240 | ||
| Doxorubicin Hydrochloride (2.0 mg/mL) >240 | ||
| 5-Fluorouracil (50.0 mg/mL) >240 | ||
| Etoposide (20.0 mg/mL) >240 | ||
| Paclitaxel (Taxol) (6.0 mg/mL) >240 | ||
| Thio-Tepa (10.0 mg/mL) >240 |
Substantial Equivalent Based on Assessment of Non-Clinical Performance 8.0 Data
The performance test data that support a determination of substantial equivalence are described above.
Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0
Clinical data are not needed for examination gloves.
Conclusion 10.0
It can be concluded that the Powder Free Nitrile Patient Examination Glove, Blue It oan of contributed (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) is safe and effective for use with chemotherapeutic agents and will perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product.
labeling claims for the procession in ly equivalent to current marketed devices. This summary will include any other information reasonably deemed necessary by the FDA.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 € 2004
Mr. KK Leong Ouality Assurance/ Regulatory Affairs Manager Perusahaan Getah Asas Sdn. Bhd. Lot 1365, Batu 17, Jalan Sungai Sembilang, 45800 Jeram, Selangor Darul Ehsan, MALAYSIA
Re: K042805
Trade/Device Name: Powdered Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claims) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: December 2, 2004 Received: December 8, 2004
Dear Mr. Leong:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Leong
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu-Ling, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042805
Device Name: Powder Free Nitrile Patient Examination Gloves Colour Blue Non-Sterile (with Low dermation Potential and Chemotherapy Drugs Protection Labeling Claims)
Indications For Use: A Powder Free Nitrile Patient Examination Glove is a dispoable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves are worn to protect against exposure to some chemotherapy drugs.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ਮ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE `on another PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qute Mchcin O 12-15-04
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(División Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: K042805
§ 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.