(162 days)
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) meets all the requirements of ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.
This document is a 510(k) premarket notification for Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black). It describes the device and compares it to a predicate device (Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green), K180476).
Since this document is for a medical glove, not an AI/ML powered medical device, the information requested in the prompt related to AI/ML device studies (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not applicable. The device's performance is demonstrated through non-clinical testing against recognized standards.
Here's a breakdown of the acceptance criteria and performance as gathered from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device, "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)," meets established standards for medical examination gloves. The key acceptance criteria and reported performance, especially concerning chemotherapy drug permeation, are detailed below. The comparison is made against the predicate device (K180476) and relevant ASTM/ISO standards.
| Characteristic | Standard/Acceptance Criteria | Predicate Device (K180476) Performance | Subject Device (K190080) Performance | Comparison |
|---|---|---|---|---|
| General | ASTM D6319-10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application | Meets ASTM D6319-10(2015) requirements | Meets ASTM D6319-10(2015) requirements | Same |
| Dimensions | ASTM 6319-10 (2015): Length-Min 240mm; Thickness palm and finger-Min 0.05mm | Length-Min 240mm; Thickness palm and finger-Min 0.05mm | Length-Min 230mm; Thickness palm and finger-Min 0.05mm | Similar |
| Physical Properties | ASTM 6319-10 (2015): Min Tensile Strength (e.g., 20.23 MPa); Min Elongation (e.g., 445%) | Min - 20.23 MPa; Min - 445% | Min - 22.31 MPa; Min - 579% | Similar |
| Thickness (Finger) | ASTM 6319-10 (2015) | 0.09 mm - 0.10 mm | 0.09 mm - 0.10 mm | Similar |
| Thickness (Palm) | ASTM 6319-10 (2015) | 0.12 mm - 0.14 mm | 0.11 mm - 0.13 mm | Similar |
| Powder Content | ASTM 6124-06 (2011): ≤ 2 mg/glove | Max - 2 mg/gloves (0.20 mg/glove reported) | Max - 2 mg/gloves (0.60 mg/glove reported) | Same |
| Chemotherapy Permeation Test | ASTM D6978-05: Breakthrough Detection Time (for most listed drugs, ≥ 240 minutes) | Similar | ||
| * Cisplatin 1.0 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Cyclophosphamide 20 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Dacarbazine 10.0 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Doxorubicin 2.0 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Etoposide 20.0 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Fluorouracil 50.0 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Paclitaxel 6.0 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Carmustine 3.3 mg/ml | *Warning for low permeation time reported | 23.4 min | 54.1 min | Improvement |
| * Thiotepa 10.0 mg/ml | *Warning for low permeation time reported | 16.2 min | 16.0 min | Similar |
| Biocompatibility | ISO 10993-10:2010 (1. Primary Skin Irritation; 2. Skin Sensitization) | 1. Not irritating; 2. Not sensitizing | 1. Not irritating; 2. Not sensitizing | Same |
| * Cytotoxicity | ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Mild cytotoxicity reactivity (score of 2) with neat extract (100%) | Mild cytotoxicity reactivity (score of 2) with neat extract (100%) | Same |
| Watertight | 21 CFR 800.20, ASTM D5151 | Passes | Passes | Same |
| Indications for Use | Intended for medical purpose to prevent contamination and protect against chemotherapy drugs (listed above). | As described for predicate device | As described for subject device | Same |
| Material | ASTM D6319-10(2015) | Nitrile | Nitrile | Same |
| Size | Medical Glove Guidance Manual - Labeling: Extra Small, Small, Medium, Large, Extra Large | Extra Small, Small, Medium, Large, Extra Large | Extra Small, Small, Medium, Large, Extra Large | Same |
| Single Use | Medical Glove Guidance Manual - Labeling | Single Use | Single Use | Same |
Study Information for the Device:
As mentioned, much of the requested information is for AI/ML devices and is not applicable to a physical medical device like examination gloves. The provided document is a 510(k) submission, confirming substantial equivalence to a predicate device based on non-clinical performance testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated but implied to be sufficient for compliance with the referenced ASTM and ISO standards for glove testing (e.g., ASTM D6978 for chemotherapy permeation, ASTM D6319 for physical properties, ISO 10993 for biocompatibility). These standards define sampling plans for lot release testing. For instance, ISO 2859 for "Sampling Procedures and Tables for Inspection by Attributes" is referenced, indicating a statistical sampling approach.
- Data Provenance: The manufacturing company is Comfort Rubber Gloves Industries Sdn. Bhd., located in Matang, Perak, Malaysia. The testing would presumably have been conducted in laboratories, potentially in Malaysia or certified testing facilities elsewhere, in accordance with the specified international standards. The data is prospective in the sense that the tests were conducted specifically for this submission.
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. The "ground truth" for a medical glove is determined by its physical and chemical properties as measured against established performance standards, not by expert interpretation of data. Laboratory testing provides the objective "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations, typically in clinical readings or image analysis for AI/ML. For glove testing, objective measurements are taken according to standard protocols.
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 medical device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" is established through objective laboratory testing results against predetermined pass/fail criteria defined by international standards (ASTM, ISO). These tests measure properties such as physical dimensions, tensile strength, elongation, powder content, integrity (watertightness), chemotherapy drug permeation time, skin irritation, sensitization, and cytotoxicity.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this type of device.
{0}------------------------------------------------
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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 27, 2019
Comfort Rubber Gloves Industries Sdn. Bhd. Chan Men QA & QMS Manager Lot 821, Jalan Matang Matang, 34750 My
Re: K190080
Trade/Device Name: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) Regulation Number: 21 CFR 880.6250
Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: March 28, 2019 Received: April 01, 2019
Dear Chan Men:
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 medical devices and radiation-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.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
Indications for Use (Describe)
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use chemotherapy drugs. Tested drugs are as follows:
| Average Breakthrough Detection Time (minutes) | |
|---|---|
| Cisplatin 1.0 mg/ml | ≥ 240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | ≥ 240 |
| Dacarbazine (DTIC) 10.0 mg/ml | ≥ 240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | ≥ 240 |
| Etoposide (Toposar) 20.0 mg/ml | ≥ 240 |
| Fluorouracil 50.0 mg/ml | ≥ 240 |
| Paclitaxel (Taxol) 6.0 mg/ml | ≥ 240 |
Please note that the following drugs have extremely low permeation time for
- Carmustine (BCNU) 3.3mg.ml - 54.1 (mins)
*Thiotepa 10.0 mg/ml - 16.0 (mins)
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.
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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
{3}------------------------------------------------
510(k) SUMMARY K190080
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLACK)
1.0 Submitter:
| Name | Comfort Rubber Gloves Industries Sdn. Bhd. |
|---|---|
| Address | Lot 821, Jalan Matang,34750 Matang, Perak, Malaysia.Malaysia. |
| Phone No. | 605-847 2777 |
| Fax No. | 605-847 9108 |
| Contact Person | Chan Yew Men (Mr.) |
Date of Preparation: June 27, 2019
2.0 Name of the Device
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
Common Name: Patient Examination Gloves
Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA) Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC
510(K) Number: K190080
3.0 Predicate Device
Device Name: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) Company: Comfort Rubber Gloves Industries Sdn. Bhd. 510(K)
No.: K180476
4.0 Description of the Device:
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) meets all the requirements of ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.
5.0 Indication for Use of the Device
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) are a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) are summarized with the following technological characteristics compared to ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in Table 1.
{4}------------------------------------------------
Chemotherapy claim is similar to Predicate, which has a gloves thickness comply with the ASTM Standards.
Table 1
| CHARACTERISTICS | STANDARDS | PREDICATE DEVICEK180476 | SUBJECT DEVICEK190080 | COMPARISON |
|---|---|---|---|---|
| Manufacturer(s) | Comfort RubberGloves IndustriesSdn. Bhd | Comfort Rubber GlovesIndustries Sdn. Bhd | Same | |
| Device Name | Powder Free NitrileExamination Gloves Testedfor Use with ChemotherapyDrugs Labeling Claim(Green) | PowderFreeNitrileExamination Gloves Testedfor Use with ChemotherapyDrugs Labeling Claim(Black) | Similar | |
| Dimension | ASTM 6319-10(2015) | Length-Min 240mmThickness palm and finger-Min 0.05mm | Length-Min 230mmThickness palm and finger-Min 0.05mm | Similar |
| Physical Properties | ASTM 6319-10(2015) | Min - 20.23MPa Min - 445% | Min - 22.31 MPaMin - 579% | Similar |
| Thickness - Finger- Palm | ASTM 6319-10(2015) | 0.09 mm- 0.10mm 0.12mm –0.14 mm | 0.09 mm- 0.10 mm0.11 mm – 0.13 mm | Similar |
| Powder Content | ASTM 6124-06(2011)(≤ 2 mg/glove) | Max - 2 mg/gloves0.20 mg/glove | Max - 2 mg/gloves0.60 mg/glove | Same |
| Chemotherapy DrugPermeation Test | ASTM D6978-05 | Below | Below | Similar |
| Test ChemotherapyDrug | Concentration | Minimum Breakthrough Detection Time (min) | ||
| *Carmustine (BCNU) | 3.3 mg/ml | 23.4 | 54.1 | |
| Cisplatin | 1.0 mg/ml | >240 | >240 | |
| Cyclophosphamide (Cytoxan) | 20 mg/ml | >240 | >240 | |
| Dacarbazine (DTIC) | 10.0 mg/ml | >240 | >240 | |
| Doxorubicin Hydrochloride | 2.0 mg/ml | >240 | >240 | |
| Etoposide (Toposar) | 20.0 mg/ml | >240 | >240 | |
| Fluorouracil | 50.0 mg/ml | >240 | >240 | |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 | >240 | |
| *Thiotepa | 10.0 mg/ml | 16.2 | 16.0 | |
| Warning Statement | * WARNING :Please note that thefollowing drugs haveextremely low permeationtimes Carmustine (BCNU):23.4 minutes and Thiotepa:16.0 minutes. | * WARNING :Please note that thefollowing drugs haveextremely low permeationtimes Carmustine (BCNU):54.1 minutes and Thiotepa:16.0 minutes. | ||
| CHARACTERISTICS | STANDARDS | PREDICATE DEVICEK180476 | SUBJECT DEVICEK190080 | COMPARISON |
| Biocompatibility | Primary Skin Irritation ISO10993-10:2010Biological evaluation ofmedical devices -- Part10: Tests for irritation andskin sensitization | Under the conditions of thestudy, the subject deviceextracts are not irritating tothe animal model. | Under the conditions of thestudy, the subject deviceextracts are not irritating tothe animal model. | Same |
| ISO 10993-10:2010Biological evaluation ofmedical devices -- Part10: Tests for irritation andskin sensitization | Under the conditions of thestudy, the subject deviceextracts are not sensitizingto the animal model. | Under the conditions of thestudy, the subject deviceextracts are not sensitizingto the animal model. | Same | |
| Cytotoxicity ISO 10993-5:2009 - Biologicalevaluation of medicaldevices -- Part 5: Tests forin vitro cytotoxicity | Under the conditions ofthe study, the subjectdevice extract exhibitsmild cytotoxicity reactivityresult (score of 2) with theneat extract (100%). | Under the conditions ofthe study, the subjectdevice extract exhibitsmild cytotoxicity reactivityresult (score of 2) with theneat extract (100%). | Same | |
| Watertight (1000ml) | 21 CFR 800.20ASTM D5151 | Passes | Passes | Same |
| Indication for Use | The Powder Free NitrileExamination Gloves Testedfor Use with ChemotherapyDrugs Labeling Claim(Green) is a specialtymedical glove which is adisposable device intendedfor medical purpose that isworn on the examiner's handor finger to preventcontamination betweenexaminer and patient. Inaddition, these gloves areworn to protect the weareragainst exposure tochemotherapy drugs.Tested chemotherapy drugsare as follows:Average BreakthroughDetection Time (minutesCisplatin, 1.0 mg/ml - ≥ 240Cyclophosphamide(Cytoxan), 20.0 mg/ml - ≥240Dacarbazine (DTIC), 10.0mg/ml - ≥ 240Doxorubicin Hydrochloride,2.0 mg/ml - ≥ 240Etoposide (Toposar), 20.0mg/ml - ≥ 240Fluorouracil, 50.0 mg/ml - ≥240Paclitaxel (Taxol), 6.0 mg/ml- ≥ 240Please note that the | The Powder Free NitrileExamination Gloves Testedfor Use with ChemotherapyDrugs Labeling Claim(Black) is a specialty medicalglove which is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand or finger toprevent contaminationbetween examiner andpatient. In addition, thesegloves are worn to protectthe wearer against exposureto chemotherapy drugs.Tested chemotherapy drugsare as follows: AverageBreakthroughDetection Time (minutes)Cisplatin, 1.0 mg/ml - ≥ 240Cyclophosphamide(Cytoxan), 20.0 mg/ml - ≥240Dacarbazine (DTIC), 10.0mg/ml - ≥ 240Doxorubicin Hydrochloride,2.0 mg/ml - ≥ 240Etoposide (Toposar), 20.0mg/ml - ≥ 240Fluorouracil, 50.0 mg/ml - ≥240Paclitaxel (Taxol), 6.0 mg/ml- ≥ 240Please note that the | Same | |
| following drugs haveextremely low permeationtime for: Carmustine (BCNU)3.3mg/ml - 23.4 (mins)Thiotepa 10.0 mg/ml -16.2 (mins | following drugs haveextremely low permeationtime for: Carmustine (BCNU)3.3mg/ml - 54.1 (mins)Thiotepa 10.0 mg/ml -16.0 (mins | |||
| Material | ASTM D6319 - 10(2015) | Nitrile | Nitrile | Same |
| Color | Green | Black | Different | |
| Size | Medical GloveGuidance ManualLabeling | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Same |
| Single Use | Medical Glove GuidanceManual -Labeling | Single Use | Single Use | Same |
{5}------------------------------------------------
{6}------------------------------------------------
7.0 Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
- ASTM D412-2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers— ● Tension
- ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an Air Oven .
- ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions ●
- ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical ● Gloves
- . ASTM D6124-2006 (Reapproved 2001) Standard Tested Method for Residual Powder on Medical Gloves
- ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application ●
- ASTM D6978-2005(Reapproved 2019) Standard Practice for Assessment of Resistance of Medical ● Gloves to Permeation by Chemotherapy Drugs
- . ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
- ISO 10993-5 Biological evaluation of medical devices-Part5 Tests for in vivo cytotoxicity ●
- ISO 10993-10 Biological evaluation of medical devices-Part 10 Test for irritation and delayed-type . hypersensitivity
8.0 Clinical Performance Data
Clinical data is not needed.
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed 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.