(258 days)
The Palm-pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove has also been tested for use with Chemotherapy Drugs.
The following Chemotherapy drugs have been tested for use with these gloves in accordance with ASTM D6978-05:
| Chemotherapy drug (concentration) | Breakthrough Detection Time |
|---|---|
| Dacarbazine (10,000 ppm) | No breakthrough up to 240 minutes |
| *Carmustine (BCNU) (3,300 ppm) | Breakthrough at 30.6 minutes |
| Cyclophosphamide (20,000 ppm) | No breakthrough up to 240 minutes |
| Doxorubicin Hydrochloride (2,000 ppm) | No breakthrough up to 240 minutes |
| Fluorrouracil (5,000 ppm) | No breakthrough up to 240 minutes |
| Cisplatin (1,000 ppm) | No breakthrough up to 240 minutes |
| Etoposide (20,000 ppm) | No breakthrough up to 240 minutes |
| Paclitaxel (6,000 ppm) | No breakthrough up to 240 minutes |
| Thiotepa (10,000 ppm) | Breakthrough at 181.3 minutes |
*Please note that the following drug has extremely low permeation times: Carmustine (BCNU): 30.6 minutes.
The Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs are patient examination gloves that worn by an examiner to prevent contamination between the patient and examiner. The gloves are suitable for use with Chemotherapy drugs, are ambidextrous and green in color. The gloves are supplied non-sterile, in boxes of 100 (measured by weight), intended for single use and are disposable.
This document describes a 510(k) premarket notification for "Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs" (K161929). The core of the submission is to demonstrate substantial equivalence to a predicate device (K141982).
This document does not describe a study involving an AI/ML device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Instead, it focuses on the equivalence of physical properties and performance to a predicate device, specifically regarding glove integrity and resistance to chemotherapy drugs.
Therefore, many of the requested criteria regarding AI/ML device testing (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, effect size of human reader improvement with AI, standalone performance, training set ground truth establishment) are not applicable to this type of medical device submission.
However, I can extract the acceptance criteria and reported "performance" based on the product's physical and chemical resistance properties as presented in the document.
Acceptance Criteria and Reported Device Performance (as applicable to a physical medical device)
The device, Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs, is assessed against standards and a predicate device. The "acceptance criteria" can be inferred from the "Meets requirements" or "Passes" statements for various tests, and in the case of chemotherapy drug permeation, the reported breakthrough times, particularly as compared to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Inferred from documentation) | Reported Device Performance (Palm-Pro Nitrile Glove) | Comparison to Predicate (K141982) |
|---|---|---|---|
| Biocompatibility (ISO 10993-10) | Non-irritating (for primary skin irritation) | Non-irritating | Met/Comparable |
| Non-sensitizing (for dermal sensitization) | Non-sensitizing | Met/Comparable | |
| Dimensions (ASTM D6319-10) | Overall length: 240mm min. | Overall length: 240mm min. | Same |
| Finger Thickness: Within 0.07-0.10mm range of predicate | Finger: 0.09 – 0.10mm | Similar (within predicate bounds) | |
| Palm Thickness: Within 0.07-0.09mm range of predicate | Palm: 0.07 – 0.08mm | Similar (within predicate bounds) | |
| Water Leak Test (ASTM D6319-10) | AQL level met | PASS (AQL level met) | Same ("Passes" for predicate) |
| Tensile Strength & Ultimate Elongation (ASTM D6319-10) | Meets requirements (pre-aging and after aging) | PASS | Same ("Meets requirements" for predicate) |
| Powder Content (ASTM D6319-10) | Residual powder content determined per glove, meets requirements (i.e., "Passes") | PASS | Same ("Passes" for predicate) |
| Freedom from holes | Passes | Passes | Same |
| Chemotherapy Drug Permeation (ASTM D6978-05) | |||
| - Dacarbazine (10,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Carmustine (BCNU) (3,300 ppm) | Breakthrough at or above 15 minutes (predicate's breakthrough time) | Breakthrough at 30.6 minutes | Higher breakthrough time for subject device (Better than predicate) |
| - Cyclophosphamide (20,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Doxorubicin Hydrochloride (2,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Fluorrouracil (5,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Cisplatin (1,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Etoposide (20,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Paclitaxel (6,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Thiotepa (10,000 ppm) | Breakthrough at or above 2.0 minutes (predicate's breakthrough time) | Breakthrough at 181.3 minutes | Higher breakthrough time for subject device (Better than predicate) |
Study Details (as applicable to a physical device)
-
Sample size used for the test set and the data provenance:
- The document states that the tests were performed "in accordance with ASTM D6319-10" and "ASTM D6978-05." These ASTM (American Society for Testing and Materials) standards typically specify the number of samples required for various physical and chemical tests (e.g., minimum number of gloves for water leak, dimensions, or permeation testing). However, the * exact sample sizes used for each test* are not explicitly stated in this summary document.
- Data Provenance: The manufacturer is Dipped Products (Thailand) Ltd., located in Thailand. The testing was conducted as "non-clinical performance data" to support the 510(k) submission, implying it was conducted as part of the device development and premarket evaluation process. It's prospective for the purpose of this submission (i.e., tests were run to demonstrate current performance for this specific device).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This criterion is not applicable as this is a physical medical device (glove) that undergoes standardized physical and chemical testing, not an AI/ML device requiring human expert annotation for "ground truth" establishment in a diagnostic context. The "ground truth" for these tests is defined by the objective measurements and pass/fail criteria of the ASTM standards.
-
Adjudication method for the test set:
- This criterion is not applicable. Adjudication (e.g., 2+1, 3+1) is a process used in medical image interpretation studies, typically for AI/ML evaluation, where multiple human readers disagree, and a tie-breaker or consensus is needed. For physical device performance tests, the results are quantitative measurements or pass/fail outcomes based on pre-defined test methodologies, not subjective interpretations requiring adjudication.
-
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic AI/ML devices where human readers (e.g., radiologists) interact with or without AI assistance. This document pertains to a physical examination glove.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This criterion is not applicable. This is a physical device, not an algorithm. The performance described is the inherent physical and chemical resistance of the glove itself.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this physical medical device, the "ground truth" is established by the standardized test methods and specifications outlined in ASTM International standards (ASTM D6319-10 for physical properties and ASTM D6978-05 for chemotherapy drug permeation). These standards define how to measure properties like dimensions, tensile strength, freedom from holes, and breakthrough times, establishing the objective and reproducible basis for performance evaluation.
-
The sample size for the training set:
- This criterion is not applicable. This is a physical glove, not an AI/ML model that undergoes "training" on a dataset.
-
How the ground truth for the training set was established:
- This criterion is not applicable for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 29, 2017
Dipped Products (Thailand) Limited % Indraj Bamrah Senior Regulatory Consultant Emergo Group 816 Congress Avenue, Suite 1400 Austin. Texas 78701
Re: K161929
Trade/Device Name: Palm-Pro Nitrile Powder Free Examination Glove, 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: February 8, 2017 Received: February 10, 2017
Received: February 19,
Dear Indraj Bamrah:
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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -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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Indications for Use
510(k) Number (if known) K161929
Device Name
Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs
Indications for Use (Describe)
The Palm-pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove has also been tested for use with Chemotherapy Drugs.
The following Chemotherapy drugs have been tested for use with these gloves in accordance with ASTM D6978-05:
| Chemotherapy drug (concentration) | Breakthrough Detection Time |
|---|---|
| Dacarbazine (10,000 ppm) | No breakthrough up to 240 minutes |
| *Carmustine (BCNU) (3,300 ppm) | Breakthrough at 30.6 minutes |
| Cyclophosphamide (20,000 ppm) | No breakthrough up to 240 minutes |
| Doxorubicin Hydrochloride (2,000 ppm) | No breakthrough up to 240 minutes |
| Fluorrouracil (5,000 ppm) | No breakthrough up to 240 minutes |
| Cisplatin (1,000 ppm) | No breakthrough up to 240 minutes |
| Etoposide (20,000 ppm) | No breakthrough up to 240 minutes |
| Paclitaxel (6,000 ppm) | No breakthrough up to 240 minutes |
| Thiotepa (10,000 ppm) | Breakthrough at 181.3 minutes |
*Please note that the following drug has extremely low permeation times: Carmustine (BCNU): 30.6 minutes.
| 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)
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Section 5 – 510(k) Summary
Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs
K161929
1. Submission Sponsor
Dipped Products (Thailand) Ltd
82/2 MOO 9, Tumbon Rattapum
Amphur Khun Nieng
Songkhla, 90220
Thailand
Phone number: +66 74302100
Contact: Mr. Nilaksha Pushpakumara
Title: Factory Manager
2. Submission Correspondent
Emergo Global Consulting, LLC
816 Congress Avenue, Suite 1400
Austin, TX 78701
Office Phone: (512) 327.9997
Contact: Indraj Bamrah, Senior Consultant, Regulatory
Email: project.management@emergogroup.com
3. Date Prepared
February 8, 2017
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4. Device Identification
| Trade/Proprietary Name: | Palm-Pro Nitrile Powder Free Examination Glove, tested for use withChemotherapy drugs |
|---|---|
| Common/Usual Name: | Patient Examination Glove |
| Classification Name: | Patient Examination Glove |
| Regulation Number: | 880.6250 |
| Product Code: | LZA, Polymer Patient Examination Glove |
| LZC, Patient Examination Glove, Specialty | |
| Device Class: | Class I |
| Classification Panel: | General Hospital |
5. Legally Marketed Predicate Device(s)
K141982, Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs, WRP Asia Pacific Sdn Bhd.
6. Device Description
The Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs are patient examination gloves that worn by an examiner to prevent contamination between the patient and examiner. The gloves are suitable for use with Chemotherapy drugs, are ambidextrous and green in color. The gloves are supplied non-sterile, in boxes of 100 (measured by weight), intended for single use and are disposable.
7. Indication for Use Statement
The Palm-pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs is a nonsterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove has also been tested for use with Chemotherapy Drugs.
The following Chemotherapy drugs have been tested for use with these gloves in accordance with ASTM D6978-05:
| Chemotherapy drug (concentration) | Breakthrough Detection Time |
|---|---|
| Dacarbazine (10,000 ppm) | No breakthrough up to 240 minute |
| *Carmustine (BCNU) (3,300 ppm) | Breakthrough at 30.6 minutes |
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| Cyclophosphamide (20,000 ppm) | No breakthrough up to 240 minutes |
|---|---|
| Doxorubicin Hydrocloride (2,000 ppm) | No breakthrough up to 240 minutes |
| Fluorrouracil (5,000 ppm) | No breakthrough up to 240 minutes |
| Cisplatin (1,000 ppm) | No breakthrough up to 240 minutes |
| Etoposide (20,000 ppm) | No breakthrough up to 240 minutes |
| Paclitaxel (6,000 ppm) | No breakthrough up to 240 minutes |
| Thiotepa (10,000 ppm) | Breakthrough at 181.3 minutes |
*Please note that the following drug has extremely low permeation times: Carmustine (BCNU): 30.6 minutes.
8. Substantial Equivalence Discussion
The following table compares the Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Table 5A - Comparison of Characteristics | ||
|---|---|---|
| -- | -- | ------------------------------------------ |
| Manufacturer | Dipped Products (Thailand) Ltd | WRP Asia Pacific Sdn Bhd | |
|---|---|---|---|
| Trade Name | Palm-Pro Powder Free NitrileExamination Glove, tested foruse with Chemotherapy drugs | Dermagrip Powder Free BlueNitrile Patient ExaminationGloves, Non-Sterile, Tested foruse with Chemotherapy Drugs | SignificantDifferences |
| 510(k) Number | K161929 | K141982 | |
| Product Code | LZC | LZC | Same |
| LZA | LZA | ||
| Regulation Number | 880.6250 | 880.6250 | Same |
| Regulation Name | Patient Examination Glove | Patient Examination Glove | Same |
| Indications for Use | The Palm-Pro Nitrile PowderFree Examination Glove, testedfor use with Chemotherapydrugs is a non-sterile disposabledevice intended for medicalpurposes that is worn on the | A patient examination glove is adisposable device intended formedical purposes that is wornon the examiner's hand or fingerto prevent contaminationbetween patient and examiner.These gloves were tested for | Similar |
| Manufacturer | Dipped Products (Thailand) Ltd | WRP Asia Pacific Sdn Bhd | Significant Differences |
| Trade Name | Palm-Pro Powder Free Nitrile Examination Glove, tested for use with Chemotherapy drugs | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs | |
| examiner's hand to prevent contamination between patient and examiner. The glove has also been tested for use with Chemotherapy Drugs.*Please note that the following drug has extremely low permeation times:Carmustine (BCNU): 30.6 minutes. | use with Chemotherapy Drugs.*Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 15 minutes and Thiotepa: 2 minutes. | ||
| Permeation times for Chemotherapy drugs | Breakthrough Detection time | Similar. The subject device when tested with Carmustine and Thiotepa are found to have higher breakthrough times than the predicate device. detection times | |
| Chemotherapy Drug tested (concentration) | |||
| Dacarbazine (10,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | |
| Carmustine (BCNU) (3,300 ppm) | Breakthrough at 30.6 minutes | 15.0 minutes | |
| Cyclophosphamide (20,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | |
| Doxorubicin Hydrochloride (2,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | |
| Fluorouracil (5,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | |
| Cisplatin (1,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | |
| Etoposide (20,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | |
| Paclitaxel (6,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | |
| Thiotepa | Breakthrough at 181.3 minutes | 2.0 minutes | |
| Manufacturer | Dipped Products (Thailand) Ltd | WRP Asia Pacific Sdn Bhd | SignificantDifferences |
| Trade Name | Palm-Pro Powder Free NitrileExamination Glove, tested foruse with Chemotherapy drugs | Dermagrip Powder Free BlueNitrile Patient ExaminationGloves, Non-Sterile, Tested foruse with Chemotherapy Drugs | |
| (10,000 ppm) | |||
| Material | Nitrile | Nitrile | Same |
| Single Use | Yes | Yes | Same |
| Dimensions | Overall length: 240mm min. | Overall length: 240mm min. | Same |
| Thickness Specification | Finger: 0.09 – 0.10mmPalm: 0.07 – 0.08mm | Finger: 0.07 – 0.10mmPalm: 0.07 – 0.09mm | Similar. Thethicknessspecificationof thesubjectdevice iswithin thebounds ofthat of thepredicatedevice. |
| Physical Properties(ASTM D6319-10) | Meets requirements | Meets requirements | Same |
| Freedom from holes | Passes | Passes | Same |
| Residue Powder Test | Passes | Passes | Same |
| Color | Green | Blue | Similar. Thegreen colordoes notraise newquestions ofsafety andeffectiveness. |
| Biocompatibility | Same | ||
| Skin Irritation(ISO 10993 - 10) | Under the conditions of thestudy, the device was non-irritating | Not a primary skin irritant underthe conditions of the study | |
| Dermal Sensitization (ISO10993 - 10) | Under the conditions of thestudy, the device was non-sensitizing | Not a contact sensitizer underthe conditions of the study |
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9. Non-Clinical Performance Data
As part of demonstrating that the Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs meets the required specifications and in showing substantial equivalence to the predicate device, Dipped Products (Thailand) Ltd. completed a number of non-clinical performance tests. The Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs meets all the requirements for overall design, performance and biocompatibility results confirming that the design output meets the design inputs and specifications for the device.
The Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Biocompatibility testing per ISO 10993-10: tests for dermal sensitization and primary skin irritation: For primary skin irritation: Under the conditions of the device was non-irritating. For dermal sensitization: Under the conditions of the device was non-sensitizing.
- . Dimension tests in accordance with ASTM D6319-10: tests for palm width, overall length, palm thickness and finger thickness: PASS
- . Water leak test in accordance with ASTM D6319-10: determination of AQL level: PASS
- . Tensile strength and ultimate elongation in accordance with ASTM D6319-10: testing conducted preaging and after aging: PASS
- . Powder content in accordance with ASTM D6319-10: residual powder content determined per glove: PASS
- . Permeation Testing for Chemotherapy Gloves in accordance with ASTM D 6978-05: Break through time tested and reported for nine drugs.
10. Statement of Substantial Equivalence
The Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device as it has the same intended use and similar technological characteristics as the previously cleared predicate device.
§ 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.