(86 days)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, the glove was tested for chemotherapy drugs permeation.
The proposed Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl is a disposable device intended for over-the-counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. The patient examination gloves are not made with natural rubber latex.
The provided document describes the acceptance criteria and study results for Powder-Free Nitrile Examination Gloves.
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Acceptance Criteria | Device Performance (Color: White, Blue, Black, Orange, Green) |
|---|---|---|
| Dimension (Length) | ASTM D6319-19 (XS: 220mm, S: 220mm, M: 230mm, L: 230mm, XL: 230mm, XXL: 230mm minimum) | All sizes and colors meet or exceed minimum length requirements (e.g., XS: 239-244mm, M: 230-245mm). |
| Dimension (Width) | ASTM D6319-19 (XS: 70±10mm, S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: 120±10mm, XXL: 130±10mm) | All sizes and colors meet width requirements (e.g., XS: 75-77mm, M: 86-97mm). |
| Dimension (Finger Thickness) | ASTM D6319-19 (0.05mm minimum) | All sizes and colors meet or exceed minimum finger thickness (e.g., White: 0.07-0.10mm, Orange: 0.27-0.28mm). |
| Dimension (Palm Thickness) | ASTM D6319-19 (0.05mm minimum) | All sizes and colors meet or exceed minimum palm thickness (e.g., White: 0.05-0.06mm, Orange: 0.18-0.22mm). |
| Freedom from Holes | ASTM D6319-19, 21 CFR 800.20 (AQL 2.5) | Passed for all sizes and colors. |
| Physical Property (Tensile Strength Before Aging) | ASTM D6319-19 (14 MPa minimum) | All sizes and colors meet or exceed 14 MPa (e.g., White: 20.5-23.2 MPa). |
| Physical Property (Elongation Before Aging) | ASTM D6319-19 (500% minimum) | All sizes and colors meet or exceed 500% (e.g., White: 520-536%). |
| Physical Property (Tensile Strength After Aging) | ASTM D6319-19 (14 MPa minimum) | All sizes and colors meet or exceed 14 MPa (e.g., White: 20.2-26.8 MPa). |
| Physical Property (Elongation After Aging) | ASTM D6319-19 (400% minimum) | All sizes and colors meet or exceed 400% (e.g., White: 427-488%). |
| Residual Powder | ASTM D6319-19 (≤ 2.0 mg of residual powder per glove) | All sizes and colors meet this requirement (e.g., White: 0.74-0.98 mg). |
| Chemotherapy Drug Permeation (Breakthrough Detection Time) | >240 minutes for most drugs (except Carmustine and ThioTepa) | Performance is explicitly listed in Table 5.1 and Table 6.3. For example, Cisplatin: >240 minutes for all colors. Carmustine and ThioTepa have lower breakthrough times and are explicitly warned against. |
| Biocompatibility (Skin Irritation) | ISO 10993-10 (Non-irritant) | Non-irritant under the conditions of the study for all colors. |
| Biocompatibility (Skin Sensitization) | ISO 10993-10 (Non-sensitizer) | Non-sensitizer under the conditions of the study for all colors. |
| Biocompatibility (Acute Systemic Toxicity) | ISO 10993-11 (Not acutely systemically toxic) | Not an acute systemic toxic under the condition of the study for all colors. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for dimensions, holes, or chemical permeation). It lists "Device Performance (Minimum)" in tables, implying that measurements were taken across a sample.
The data provenance is not explicitly mentioned (e.g., country of origin for the testing or if it was retrospective/prospective). However, the submitter's address is Malaysia: "Lot 18256, Kawasan Perindustrian Lot Q, Kertih Bio-Polymer Park, 24300 Kemaman, Terengganu, Malaysia." The testing standards cited are international (ASTM, ISO).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is a medical glove, and the "ground truth" for its performance is established through objective, standardized physical and chemical permeation tests, and biocompatibility studies, not through expert consensus or interpretation of medical images/conditions. The performance is measured against established scientific and engineering standards (ASTM and ISO).
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements against defined standards, not subjective interpretations requiring adjudication.
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 not an AI-powered diagnostic or interpretive device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device (glove), not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for the performance of the medical gloves is established through:
- Standardized Physical and Mechanical Testing: Against ASTM D6319-19 requirements for dimensions, tensile strength, elongation, and residual powder.
- Permeation Testing: Against ASTM D6978-05 for chemotherapy drugs.
- Biocompatibility Testing: Against ISO 10993-5 (In Vitro Cytotoxicity - although the proposed device showed potential cytotoxicity, it was then deemed safe by the Acute Systemic Toxicity test), ISO 10993-10 for skin irritation and sensitization, and ISO 10993-11 for acute systemic toxicity.
These are all objective, laboratory-based measurement criteria rather than expert consensus, pathology, or outcomes data in a clinical setting.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical device.
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May 27, 2022
Encompass Industries Sdn. Bhd. Nur Muhyiddin OA Manager Lot 18256, Kawasan Perindustrian Lot Q Kertih BioPolymer Park Kemaman, Terengganu 24300 Malaysia
Re: K220609
Trade/Device Name: Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: February 24, 2022 Received: March 2, 2022
Dear Nur Muhyiddin:
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.
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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.
Bifeng Qian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220609
Device Name
Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Indications for Use (Describe)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, the glove was tested for chemotherapy drugs permeation.
The following chemotherapy drugs have been tested with the glove:
| Chemotherapy Drugs | Concentration | Breakthrough Detection Time in Minutes | ||||
|---|---|---|---|---|---|---|
| White | Blue | Black | Orange | Green | ||
| Carmustine | 3.3 mg/ml | 11.2 | 10.7 | 11.0 | 67.3 | 67.1 |
| Cisplatin | 1.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Cyclophosphamide | 20.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Dacarbazine | 10.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Doxorubicin HCL | 2.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Etoposide | 20.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Fluorouracil | 50.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Methotrexate | 25.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Paclitaxel | 6.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| ThioTepa | 10.0 mg/ml | 25.2 | 21.5 | 11.1 | 47.8 | 169.1 |
| Mitomycin C | 0.5 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Vincristine Sulfate | 1.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Fentanyl Citrate | 100 mcg/2mL | >240 | >240 | >240 | >240 | >240 |
*Please note that the following 2 drugs have extremely low permeation times:
-
- Carmustine
-
- Thiotepa
Warning: Do not use with Carmustine and ThioTepa.
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.
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510(k) Summary
K220609
Preparation date: May 27, 2022
| 1. Submitter | ||
|---|---|---|
| Name | : | Encompass Industries Sdn. Bhd. |
| Address | : | Lot 18256, Kawasan Perindustrian Lot Q,Kertih Bio-Polymer Park, 24300 Kemaman,Terengganu, Malaysia. |
| Telephone No. | : | +609 831 8866 |
| Contact Person | : | Nur Atikah binti Muhammad Muhyiddin |
| : | regulatory@encompass-medical.com atikah@ems-inc.com |
2. Identification of Device
| Trade/Proprietary Name(s) | : 1. Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl2. Other clients' trade name and private labeling |
|---|---|
| Common Name(s) | : Powder-Free Nitrile Examination Glove |
| Classification Name: | : 1. Non-powdered Patient Examination Glove (21 CFR 880.6250)2. Patient Examination Glove, Specialty (Product Code: LZC)3. Polymer Patient Examination Glove (Product Code: LZA) |
| Device Classification | : Class I |
3. Identification of Legally Marketed Device as Predicate
| Predicate name | : Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile,Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
|---|---|
| 510(k) number | : K200181 |
| Company | : Comfort Rubber Glove Industries Sdn Bhd |
4. Description of Device
The proposed Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl is a disposable device intended for over-the-counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. The patient examination gloves are not made with natural rubber latex. General specifications of the glove are as below:
| 1. Overall Length | : | 230 mm minimum |
|---|---|---|
| 2. Width | : | 95 ± 5 mm minimum (for medium glove) |
| 3. Palm Thickness | : | 0.05 mm minimum |
| 4. Finger Thickness | : | 0.05 mm minimum |
| 5. Tensile Strength | ||
| a. Before Aging | : | 14 MPa minimum |
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| b. After Aging | : | 14 MPa minimum |
|---|---|---|
| 6. Ultimate Elongation | ||
| a. Before Aging | : | 500 % minimum |
| b. After Aging | : | 400 % minimum |
| 7. Pinhole AQL | : | 2.5 |
5. Intended Use / Indication for Use:
A Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for chemotherapy drugs permeation test.
Table 5.1 Summary Test Results for Resistance of Powder-Free Nitrile Examination Gloves (White, Blue, Black, Orange and Green Color) to Permeation by Chemotherapy Drugs
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time (minutes) | ||||
|---|---|---|---|---|---|---|
| White | Blue | Black | Orange | Green | ||
| Carmustine (BCNU)* | 3.3 mg/ml | 11.2 | 10.7 | 11.0 | 67.3 | 67.1 |
| Cisplatin | 1.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Cyclophosphamide | 20.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Dacarbazine | 10.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Doxorubicin HCL | 2.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Etoposide | 20.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Fluorouracil | 50.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Methotrexate | 25.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Paclitaxel | 6.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| ThioTepa* | 10.0 mg/mL | 25.2 | 21.5 | 11.1 | 47.8 | 169.1 |
| Mitomycin C | 0.5 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Vincristine Sulfate | 1.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Fentanyl Citrate | 100.0 mcg/2mL | >240 | >240 | >240 | >240 | >240 |
| *Please note that the following drugs have extremely low permeation time: | ||||||
| 1. Carmustine (3.3 mg/mL) |
- Thiotepa (10 mg/mL)
Warning: Do not use with Carmustine and ThioTepa.
6. Comparative Technological Characteristics & Performance Information Summary
Table 6.1 Summary of Technological Characteristics Comparison between Proposed Device and Predicate Device
| Device Performance / Characteristic | Comparison Analysis | ||||
|---|---|---|---|---|---|
| Character-istics | Requirement /Standard | Predicate Device(K200181) | Subject Device | Comparison | AnySafety &Effective-ness Issue |
| Material | - | Nitrile | Nitrile | Similar | No |
| Color | - | Black | WhiteBlueBlackOrangeGreen | MinorDifferent(Supported byBiocompatibility Study) | No |
| ProductCode | LZALZC | LZALZC | Similar | No | |
| Type ofUse | - | Single Use | Single Use | Similar | No |
| Material | - | Nitrile | Nitrile | Similar | No |
| Powder-Free | - | Yes | Yes | Similar | No |
| Sterility | - | Non-sterile | Non-Sterile | Similar | No |
| IntendedUse /Indicationsfor Use | - | The Black Colored,Powder Free NitrileExamination Gloves,Non-Sterile, and Testedfor Use withChemotherapy Drugs andFentanyl Citrate is aspecialty medical glovewhich is a disposabledevice intended formedical purposes that isworn on the examiner'shand or finger to preventcontamination betweenexaminer and patient. Inaddition, these gloves areworn to protect thewearer against exposureto chemotherapy drugsand Fentanyl Citrate. | Powder-Free NitrileExamination Glove (White,Blue, Black, Orange andGreen Color) Tested forUse with ChemotherapyDrugs and Fentanyl is adisposable device intendedfor medical purposes that isworn on the examiner'shand, in order to preventcontamination betweenpatient and examiner, andalso prevent transmission ofa wide variety of diseases toboth patient and health carepersonnel. In addition,these gloves were tested forchemotherapy drugpermeation test. | Similar | No |
| Dimension | ASTM D6319-10 | Meets requirement | Meets requirement | Similar | No |
| PhysicalProperties | ASTM D6319-10 | Meets requirement | Meets requirement | Similar | No |
| Freedomfrom Holes | ASTM D6319-10(Tested accordingto ASTM D5151-06) | Meets requirements ofASTM D6319-10(ASTM D5151) | Meets ASTM D6319-10,21 CFR 800.20 (Tested inaccordance with ASTMD5151-06) | Similar | No |
| PowderResidual | ASTM D6124-06 | Meets requirement | Meets requirement | Similar | No |
| Biocompatibility | .In VitroCytotoxicity-ISO 10993-5 | Under the conditions ofthe study, the device isnon-cytotoxic | Under the condition ofstudy, the device extractshows potential toxicity. | Different(Supported byAcuteSystemicToxicityStudy) | No |
| Acute SystemicToxicity - ISO10993-11 | - | Not an acute systemic toxicunder the condition of thestudy. | Different(Device isproven safe toused) | No | |
| Skin Sensitization- ISO 10993-10 | Under the condition ofthe study, the device isnon-sensitization | Not a sensitizer under theconditions of the study. | Similar | No | |
| Skin Irritation -ISO 10993-10 | Under the conditions ofthe study, the device isnon irritating | Not a primary skin irritantunder the conditions of thestudy. | Similar | No |
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| Characteristic | Predicate Device(K200181) | Proposed Device | Comparison Analysis | Justification |
|---|---|---|---|---|
| Color | Black | WhiteBlueBlackOrangeGreen | Minor Different(Supported byBiocompatibilityStudy) | Device in different color hasthe same non-sensitization,non-irritating and non-toxiccharacteristics. |
| Biocompatibility(In VitroCytotoxicity) | Meets ISO 10993:5Under theconditions of thestudy, the device isnon-cytotoxic | ISO 10993:5Under the condition ofthe study, thedevice extract shows potentialcytotoxicity. | Different(Supported byAcute SystemicToxicity Study) | Device has potential cytotoxiceffect. Therefore, AcuteSystemic Toxicity test isconducted to prove thatdevice does not have potentialtoxicity. |
| Biocompatibility(Acute SystemicToxicity) | - | Meets ISO 10993-11Not an acute systemictoxic under thecondition of the study. | Different(Device is provensafe to use) | Device is does not havepotential toxicity effect.Therefore, similar with thepredicate. |
Table 6.2 Summary of Difference in Technological Characteristics
Table 6.3: Test Results for Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (ASTM D6978-05)
| ChemotherapyDrug | Concentration | Minimum Breakthrough Detection Time (minutes) | |||||
|---|---|---|---|---|---|---|---|
| Predicate Device(K200181) | Proposed Device | ||||||
| White | Blue | Black | Orange | Green | |||
| Carmustine (BCNU)* | 3.3 mg/ml | 54.1 | 11.2 | 10.7 | 11.0 | 67.3 | 67.1 |
| Cisplatin | 1.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Cyclophosphamide | 20.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Dacarbazine | 10.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Doxorubicin HCL | 2.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Etoposide | 20.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Fluorouracil | 50.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Methotrexate | 25.0 mg/mL | - | >240 | >240 | >240 | >240 | >240 |
| Paclitaxel | 6.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| ThioTepa* | 10.0 mg/mL | 1.3 | 25.2 | 21.5 | 11.1 | 47.8 | 169.1 |
| Mitomycin C | 0.5 mg/mL | - | >240 | >240 | >240 | >240 | >240 |
| Vincristine Sulfate | 1.0 mg/mL | - | >240 | >240 | >240 | >240 | >240 |
| Fentanyl Citrate | 100.0 mcg/2mL | >240 | >240 | >240 | >240 | >240 | >240 |
| *Warning Statement: | The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time:1. Carmustine (3.3 mg/mL)2. Thiotepa (10 mg/mL) |
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7. Summary of Non-Clinical Test:
Below are the non-clinical tests that was conducted and the purposes:
| Test | Purpose |
|---|---|
| Dimension Test | To evaluate whether the device meets the current ASTM D6319-19 |
| Freedom From Hole | To evaluate whether the subject meets current 21 CFR 800.20, ASTMD6319-19 and test according to ASTM D5151-19 |
| Physical Property Test | To evaluate whether the subjects meet current ASTM D6319-19 and testaccording to ASTM D412 and ASTM D573 |
| Residual Powder Test | To evaluate whether the subjects meet current ASTM D6319-19 and testaccording to ASTM D6124-06 |
| Biocompatibility Test(Skin Irritation) | To determine whether skin irritation potential of device meets ISO 10993-10. |
| Biocompatibility Test(Skin Sensitization) | To determine whether skin sensitization potential of device meets ISO10993-10. |
| Biocompatibility Test(Acute SystemicToxicity) | To determine whether leachable extracted from the device would causeacute systemic toxicity and meet ISO 10993-11. |
Table 7.1 Summary of Dimension Test
| Standard | Minimum | Device Performance (Minimum) | ||||||
|---|---|---|---|---|---|---|---|---|
| Characteristics | Size | Requirement | White | Blue | Black | Orange | Green | |
| Length | ASTMD6319-19 | XS | 220 mm | 239 mm | 235 mm | 242 mm | 243 mm | 244 mm |
| S | 220 mm | 236 mm | 237 mm | 242 mm | 244 mm | 241 mm | ||
| M | 230 mm | 230 mm | 230 mm | 240 mm | 245 mm | 245 mm | ||
| L | 230 mm | 234 mm | 237 mm | 255 mm | 243 mm | 242 mm | ||
| XL | 230 mm | 232 mm | 246 mm | 240 mm | 240 mm | 245 mm | ||
| XXL | 230 mm | 238 mm | 238 mm | 242 mm | 240 mm | 245 mm | ||
| Width | ASTMD6319-19 | XS | $70 \pm 10$ mm | 75 mm | 77 mm | 77 mm | 77 mm | 77 mm |
| S | $80 \pm 10$ mm | 85 mm | 87 mm | 86 mm | 87 mm | 85 mm | ||
| M | $95 \pm 10$ mm | 93 mm | 86 mm | 92 mm | 97 mm | 97 mm | ||
| L | $110 \pm 10$ mm | 104 mm | 107 mm | 104 mm | 108 mm | 107 mm | ||
| XL | $120 \pm 10$ mm | 112 mm | 111 mm | 114 mm | 118 mm | 117 mm | ||
| XXL | $130 \pm 10$ mm | 128 mm | 128 mm | 127 mm | 124 mm | 126 mm | ||
| Thickness(Finger) | ASTMD6319-19 | XS | 0.05 mm | 0.08 mm | 0.08 mm | 0.09 mm | 0.27 mm | 0.25 mm |
| S | 0.08 mm | 0.09 mm | 0.05 mm | 0.27 mm | 0.27 mm | |||
| M | 0.10 mm | 0.11 mm | 0.10 mm | 0.28 mm | 0.27 mm | |||
| L | 0.09 mm | 0.08 mm | 0.10 mm | 0.27 mm | 0.27 mm | |||
| XL | 0.07 mm | 0.06 mm | 0.10 mm | 0.28 mm | 0.27 mm | |||
| XXL | 0.07 mm | 0.08 mm | 0.07 mm | 0.28 mm | 0.26 mm | |||
| Thickness(Palm) | ASTMD6319-19 | XS | 0.05 mm | 0.05 mm | 0.05 mm | 0.06 mm | 0.19 mm | 0.19 mm |
| S | 0.05 mm | 0.05 mm | 0.06 mm | 0.19 mm | 0.19 mm | |||
| M | 0.06 mm | 0.06 mm | 0.05 mm | 0.19 mm | 0.18 mm | |||
| L | 0.05 mm | 0.05 mm | 0.06 mm | 0.22 mm | 0.20 mm | |||
| XL | 0.05 mm | 0.05 mm | 0.06 mm | 0.22 mm | 0.18 mm | |||
| XXL | 0.05 mm | 0.05 mm | 0.06 mm | 0.20 mm | 0.19 mm |
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| Characteristics | Standard | Size | MinimumRequirement | Device Performance (Minimum) | ||||
|---|---|---|---|---|---|---|---|---|
| White | Blue | Black | Orange | Green | ||||
| Freedom fromHoles | A;STMD6319-1921 CFR800.20(Testedas perASTMD5151-19) | XS | AQL 2.5 | Passed | Passed | Passed | Passed | Passed |
| S | Passed | Passed | Passed | Passed | Passed | |||
| M | Passed | Passed | Passed | Passed | Passed | |||
| L | Passed | Passed | Passed | Passed | Passed | |||
| XL | Passed | Passed | Passed | Passed | Passed | |||
| XXL | Passed | Passed | Passed | Passed | Passed |
Table 7.2 Summary of Freedom of Hole Test
Table 7.3 Summary of Physical Property Test
| Characteristics | Standard | Size | MinimumRequirement | Device Performance (Minimum) | ||||
|---|---|---|---|---|---|---|---|---|
| White | Blue | Black | Orange | Green | ||||
| Before Aging(Tensile [MPa]) | XS | 14 MPa | 23.2 | 21.0 | 21.3 | 20.7 | 21.1 | |
| S | 21.2 | 24.5 | 23.6 | 20.0 | 20.1 | |||
| M | 22.8 | 21.6 | 22.3 | 21.0 | 28.8 | |||
| L | 20.7 | 23.7 | 21.6 | 21.4 | 20.9 | |||
| XL | 20.5 | 20.2 | 24.3 | 20.9 | 22.0 | |||
| XXL | 22.8 | 23.6 | 22.2 | 23.0 | 22.1 | |||
| Before Aging(Elongation[%]) | ASTMD6319-19 | XS | 500 % | 528 | 520 | 515 | 527 | 533 |
| S | 527 | 549 | 518 | 515 | 556 | |||
| M | 520 | 522 | 530 | 549 | 548 | |||
| L | 528 | 521 | 527 | 531 | 523 | |||
| XL | 536 | 521 | 528 | 533 | 524 | |||
| XXL | 526 | 524 | 528 | 525 | 525 | |||
| After Aging(Tensile [MPa]) | (Testedas perASTMD412-16) | XS | 14 MPa | 23.0 | 20.2 | 23.0 | 24.5 | 21.4 |
| S | 20.2 | 24.6 | 26.6 | 22.7 | 20.4 | |||
| M | 26.8 | 19.8 | 22.7 | 22.2 | 26.4 | |||
| L | 24.9 | 26.1 | 21.4 | 25.2 | 21.7 | |||
| XL | 26.3 | 23.1 | 28.8 | 22.2 | 24.6 | |||
| XXL | 23.3 | 21.0 | 20.0 | 27.4 | 20.1 | |||
| After Aging(Elongation[%]) | XS | 400 % | 432 | 461 | 414 | 430 | 465 | |
| S | 427 | 466 | 421 | 412 | 446 | |||
| M | 444 | 457 | 425 | 466 | 440 | |||
| L | 488 | 423 | 436 | 447 | 455 | |||
| XL | 458 | 424 | 434 | 432 | 431 | |||
| XXL | 437 | 435 | 433 | 425 | 425 |
{10}------------------------------------------------
| Characteristics | Standard | Size | MinimumRequirement | Device Performance (Minimum) | ||||
|---|---|---|---|---|---|---|---|---|
| White | Blue | Black | Orange | Green | ||||
| ResidualPowder(mg) | ASTMD6319-19(Testedas perASTMD6124-06) | XS | ≤ 2.0 mg ofresidualpowder perglove | 0.98 | 0.68 | 0.80 | 0.82 | 0.96 |
| S | 0.86 | 0.72 | 0.86 | 0.98 | 0.82 | |||
| M | 0.92 | 0.88 | 0.94 | 0.92 | 0.92 | |||
| L | 0.78 | 0.76 | 0.92 | 0.78 | 0.90 | |||
| XL | 0.84 | 0.98 | 0.84 | 0.68 | 0.86 | |||
| XXL | 0.74 | 0.82 | 0.92 | 0.84 | 0.98 |
Table 7.4 Summary of Residual Powder Test
Table 7.5 Summary of Biocompatibility Test
| Characteristics | Standard | MinimumRequirement | Device Performance | ||||
|---|---|---|---|---|---|---|---|
| White | Blue | Black | Orange | Green | |||
| Skin Irritation | ISO 10993-10 | N/A | Non-irritant under the conditions of the study. | ||||
| SkinSensitization | ISO 10993-10 | N/A | Non-sensitizer under the conditions of the study. | ||||
| Acute SystemicToxicity | ISO 10993-11 | N/A | Not an acute systemic toxic under the condition ofthe study. |
8. Summary of Clinical Test:
Clinical data is not required.
9. Conclusion:
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed 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.