(258 days)
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No
The document describes a physical medical device (examination gloves) and its performance characteristics, with no mention of software, algorithms, or data processing that would involve AI or ML.
No.
The "Intended Use" states that the device 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." This describes a barrier, not a device that treats or cures a disease or condition.
No
This device is an examination glove, worn to prevent contamination between the patient and examiner. It is not designed to diagnose any condition or disease. Its function is protective.
No
The device is a physical examination glove, which is a hardware medical device, not software. The summary describes physical properties and performance tests related to the material and structure of the glove.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases, conditions, or infections. This device does not perform any such tests.
- Device Description: The description reinforces its function as a patient examination glove for preventing contamination.
- Performance Studies: The performance studies focus on the physical properties of the glove (dimensions, water leak, tensile strength, powder content) and its barrier properties against chemotherapy drugs. These are not diagnostic tests.
The testing for use with chemotherapy drugs relates to the glove's barrier function and safety for the user when handling these substances, not to any diagnostic purpose.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hand
Indicated Patient Age Range
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Intended User / Care Setting
Examiner (medical purposes)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance tests were completed.
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 device passed all testing in accordance with internal requirements, national standards, and international standards to support substantial equivalence.
Key tests included:
- Biocompatibility testing per ISO 10993-10: tests for dermal sensitization and primary skin irritation. Key result: non-irritating and non-sensitizing.
- Dimension tests in accordance with ASTM D6319-10: tests for palm width, overall length, palm thickness and finger thickness. Key result: PASS.
- Water leak test in accordance with ASTM D6319-10: determination of AQL level. Key result: PASS.
- Tensile strength and ultimate elongation in accordance with ASTM D6319-10: testing conducted preaging and after aging. Key result: PASS.
- Powder content in accordance with ASTM D6319-10: residual powder content determined per glove. Key result: PASS.
- Permeation Testing for Chemotherapy Gloves in accordance with ASTM D 6978-05: Break through time tested and reported for nine drugs. Key results are listed in the "Intended Use / Indications for Use" section.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
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
1
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 with
Chemotherapy 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 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 | Significant | ||
| Differences | |||
| 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 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 | A 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. | |||
| 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 | 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 | |||
| (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 – 0.10mm | ||
| Palm: 0.07 – 0.08mm | Finger: 0.07 – 0.10mm | ||
| Palm: 0.07 – 0.09mm | Similar. The | ||
| thickness | |||
| specification | |||
| of the | |||
| subject | |||
| device is | |||
| within the | |||
| bounds of | |||
| that of the | |||
| predicate | |||
| device. | |||
| 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. The |
| green color | |||
| does not | |||
| raise new | |||
| questions of | |||
| safety and | |||
| effectiveness. | |||
| Biocompatibility | Same | ||
| Skin Irritation | |||
| (ISO 10993 - 10) | Under the conditions of the | ||
| study, the device was non- | |||
| irritating | Not a primary skin irritant under | ||
| the conditions of the study | |||
| Dermal Sensitization (ISO | |||
| 10993 - 10) | Under the conditions of the | ||
| study, the device was non- | |||
| sensitizing | Not a contact sensitizer under | ||
| the 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.