(103 days)
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.
The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 12.3 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 17.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from synthetic polyisoprene latex.
The provided documents describe the acceptance criteria and performance of the Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs. This is a medical device, and the information is presented as part of an FDA 510(k) premarket notification.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria and device performance is detailed in the "TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE" and the "SUMMARY OF NON-CLINICAL TESTING" sections.
| Characteristic / Test Methodology | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Chemotherapy Drugs Permeation | ASTM D6978-05 (Reapproved 2019): Under the conditions of the study, no permeation. | Carmustine (3.3 mg/ml): 12.3 minutesCisplatin (1.0 mg/ml): > 240 minutesCyclophosphamide (20.0 mg/ml): > 240 minutesDacarbazine (10.0 mg/ml): > 240 minutesDoxorubicin Hydrochloride (2.0 mg/ml): > 240 minutesEtoposide (20.0 mg/ml): > 240 minutesFluorouracil (50.0 mg/ml): > 240 minutesMethotrexate (25.0 mg/ml): > 240 minutesMitomycin C (0.5 mg/ml): > 240 minutesPaclitaxel (6.0 mg/ml): > 240 minutesThiotepa (10.0 mg/ml): 17.4 minutesVincristine Sulfate (1.0 mg/ml): > 240 minutesNote: Carmustine and Thiotepa had extremely low permeation times, leading to a "Do not use" warning. |
| Freedom from Holes | ASTM D3577-19 requirements of AQL 1.5 | Meets ASTM D3577-19 requirements of AQL 1.5 |
| Length (ASTM D3577-19) | Varies by size (e.g., 5.5: Min 245mm, 6.0-9.0: Min 265mm) | Meets ASTM D3577-19 requirements for length (e.g., Size 5.5: 285mm, Size 9.0: 291mm) |
| Width (ASTM D3577-19) | Varies by size (e.g., 5.5: 70 ± 6mm, 9.0: 114 ± 6mm) | Meets ASTM D3577-19 requirements for width (e.g., Size 5.5: 74mm, Size 9.0: 116mm) |
| Thickness (ASTM D3577-19) | Palm, Finger, Cuff Minimum 0.10 mm | Meets ASTM D3577-19 requirements for thickness (e.g., Palm: 0.19-0.21mm, Finger: 0.23-0.24mm, Cuff: 0.15-0.16mm) |
| Tensile Strength (ASTM D3577-19) | Before Aging: ≥ 17 MPaAfter Aging: ≥ 12 MPa | Before Aging: Average 17.9 MPaAfter Aging: Average 15.2 MPa |
| Ultimate Elongation (ASTM D3577-19) | Before Aging: ≥ 650 %After Aging: ≥ 490 % | Before Aging: Average 952 %After Aging: Average 940 % |
| Stress at 500% Elongation (ASTM D3577-19) | Max 7.0 MPa (Before Aging) | Average 2.2 MPa (Before Aging) |
| Powder Residual (ASTM D6124-06 (2017)) | ≤ 2 mg per glove | Average 0.34 mg/glove |
| In Vitro Cytotoxicity (ISO 10993-5) | Not cytotoxic | Found to be cytotoxic, but further evaluation (ISO 10993-11) showed no systemic toxicity. |
| Primary Skin Irritation (ISO 10993-10) | Not an irritant | Not an irritant |
| Dermal Sensitization (ISO 10993-10) | Not a sensitizer | Not a sensitizer |
| Acute Systemic Toxicity (ISO 10993-11) | Does not pose a toxicity concern | No signs of toxicity |
| Pyrogenicity Test (USP <151>) | Non-pyrogenic | Non-pyrogenic |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test in the "test set" (i.e., the data used to prove the device meets acceptance criteria). However, it lists recognized industry standards (ASTM, ISO, USP) for each test. These standards typically define minimum sample sizes for testing to ensure statistical validity.
The data provenance can be inferred based on the applicant information:
- Country of Origin of the Data: The applicant is Hartalega NGC Sdn. Bhd., located in Sepang, Selangor, Malaysia. Therefore, the testing was likely conducted in Malaysia or by laboratories commissioned by the Malaysian company.
- Retrospective or Prospective: These are non-clinical (laboratory) tests performed on the device to demonstrate its properties. This would be considered prospective in the sense that the tests were specifically conducted to evaluate this new device for regulatory submission, not retrospectively analyzed from existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the evaluation relies on objective, standardized laboratory tests (e.g., chemical permeation, physical property measurements, biocompatibility assays) rather than expert interpretation of a "test set" in the context of medical imaging or diagnostic algorithms. The "ground truth" is established by the defined parameters and methodologies of the ASTM, ISO, and USP standards.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation relies on objective, standardized laboratory tests. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers and subjective interpretations, such as radiology image reviews.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "CLINICAL PERFORMANCE DATA: Not applicable. There was no clinical data required to support the subject device as the indication for use is equivalent to the predicate device." MRMC studies are used to evaluate the diagnostic performance of devices, often medical imaging AI, with human-in-the-loop scenarios. This document describes the performance of a physical medical device (surgical glove) through non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical surgical glove, not an algorithm or AI system. The tests evaluate the physical and chemical properties of the glove itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on established standard test methodologies and defined acceptance criteria set by organizations like ASTM, ISO, and USP. These are objective measurements:
- Physical measurements (length, width, thickness)
- Mechanical properties (tensile strength, elongation)
- Chemical resistance (breakthrough time for chemotherapy drugs)
- Biological safety (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity)
It does not involve expert consensus, pathology, or outcomes data in the typical sense of AI/diagnostic device evaluation.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set. The term "training set" refers to data used to train an algorithm.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as Section 8.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 24, 2022
Hartalega NGC SDN BHD Nurul Kong Deputy General Manager - Quality Assurance NO. 1 Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang, Selangor Darul Ehsan 43900 Malaysia
Re: K221718
Trade/Device Name: Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: August 15, 2022 Received: August 23, 2022
Dear Nurul Kong:
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 mediation-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 Oian.M.D.,Ph.D. Assistant Director 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221718
Device Name
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.
The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 12.3 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 17.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.
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)
× Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY (K221718)
FOR
POLYISOPRENE POWDER FREE SURGICAL GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
(The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92)
APPLICANT INFORMATION
| Date Prepared | : April 27, 2022 |
|---|---|
| Name | : Hartalega NGC Sdn. Bhd. |
| Address | : No. 1, Persiaran Tanjung,Kawasan Perindustrian Tanjung,43900 Sepang, Selangor,Malaysia |
| Establishment Registration Number | : 3011200663 |
CORRESPONDENT AND/OR PREPARER INFORMATION
| Contact Name | : | Nurul Aisyah Kong |
|---|---|---|
| Contact Title | : | Deputy General Manager – Quality Assurance |
| Phone Number | : | (603) 3280 3888 |
| Fax Number | : | (603) 3271 0135 |
| Contact Email | : | wkkong@hartalega.com.my |
DEVICE IDENTIFICATION
| Common Name of the Device | : | Surgeon's Glove |
|---|---|---|
| Trade Name (Proprietary Name) | : | Polyisoprene Powder Free Surgical Glove Tested for Use withChemotherapy Drugs |
| Device Class | : | 1 |
| Product Code | : | KGO, LZC |
| Regulation Number | : | 21 CFR 878.4460 |
| Reason for 510(k) Submission | : | New device |
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PREDICATE DEVICE INFORMATION
| 510(k) Number | Tradename | Product Code |
|---|---|---|
| K190018 | Gammex Non-Latex Polyisoprene White Surgical Gloves Tested forUse with Chemotherapy Drugs | KGO |
DESCRIPTION OF THE DEVICE:
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from synthetic polyisoprene latex.
INDICATIONS FOR USE:
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.
The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 12.3 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 17.4 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa
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TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE:
| CharacteristicsandParameters | Subject Device | Predicate Device(K190018) | Discussion | ||
|---|---|---|---|---|---|
| Trade Name | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs | Gammex Non-Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs | Different | ||
| Applicant | Hartalega NGC Sdn. Bhd. | Ansell Healthcare Products LLC | Different | ||
| Product Code | KGO, LZC | KGO | Similar | ||
| Classification | 1 | 1 | Similar | ||
| RegulationNumber | 21 CFR 878.4460 | 21 CFR 878.4460 | Similar | ||
| RegulationName | Surgeon's Glove | Surgeon's Glove | Similar | ||
| Indications forUse | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are intended to be worn by operating room personnel to protect a surgical wound from contamination.These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Similar | ||
| ChemotherapyDrug andConcentration | MinimumBreakthroughDetection Time inMinutes | ChemotherapyDrug andConcentration | MinimumBreakthroughDetection Time inMinutes | ||
| Carmustine(3.3 mg/ml) | 12.3 | Carmustine(3.3 mg/ml) | 10.2 | Performancelevel forCarmustine andThiotepabetween subjectdevice andpredicate deviceis comparable.AdditionalChemotherapydrugs weretested on thepredicatedevice. | |
| Cisplatin(1.0 mg/ml) | > 240 | Cisplatin(1.0 mg/ml) | > 240 | ||
| Cyclophosphamide(20.0 mg/ml) | > 240 | Cyclophosphamide(20.0 mg/ml) | > 240 | ||
| TestChemotherapyDrugs | Dacarbazine(10.0 mg/ml) | > 240 | Dacarbazine(10.0 mg/ml) | > 240 | |
| DoxorubicinHydrochloride(2.0 mg/ml) | > 240 | DoxorubicinHydrochloride(2.0 mg/ml) | > 240 | ||
| Etoposide(20.0 mg/ml) | > 240 | Etoposide(20.0 mg/ml) | > 240 | ||
| Fluorouracil(50.0 mg/ml) | > 240 | Fluorouracil(50.0 mg/ml) | > 240 | ||
| Methotrexate(25.0 mg/ml) | > 240 | Methotrexate(25.0 mg/ml) | > 240 | ||
| Mitomycin C(0.5 mg/ml) | > 240 | Mitomycin C(0.5 mg/ml) | > 240 | ||
| Paclitaxel(6.0 mg/ml) | > 240 | Paclitaxel(6.0 mg/ml) | > 240 | ||
| Thiotepa(10.0 mg/ml) | 17.4 | Thiotepa(10.0 mg/ml) | 11.5 |
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| CharacteristicsandParameters | Subject Device | Predicate Device (K190018) | Discussion | ||
|---|---|---|---|---|---|
| Vincristine Sulfate(1.0 mg/ml)> 240Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.Warning: Do not use with Carmustine and Thiotepa | Vincristine Sulfate (1.0 mg/ml) > 240Blenoxane (15 mg/ml) > 240Busulfan (6 mg/ml) > 240Cytarabine (100 mg/ml) > 240Daunorubicin (5 mg/ml) > 240Docetaxel (10.0 mg/ml) > 240Fludarabine (25 mg/ml) > 240Gemcitabine (38 mg/ml) > 240Idarubicin (1 mg/ml) > 240Ifosfamide (50.0 mg/ml) > 240Irinotecan (20.0 mg/ml) > 240Mechlorethamine HCI (1.0 mg/ml) > 240Melphalan (5 mg/ml) > 240Mitoxantrone (2.0 mg/ml) > 240Oxaliplatin (2.0 mg/ml) > 240Paraplatin (10 mg/ml) > 240Ellence (2 mg/ml) > 240Rituximab (10 mg/ml) > 240Please note that the following drugs have extremely low permeation times:Carmustine (BCNU): 10.2 minutes and Thiotepa:11.5 minutes.Warning: Do not use with Carmustine and Thiotepa | ||||
| Type of use | Over the counter use | Over the counter use | Similar | ||
| Materials | Polyisoprene | Polyisoprene | Similar | ||
| Color | Natural | White | Different | ||
| Design | • Single Use• Sterile• Powder-Free• Hand Specific | • Single Use• Sterile• Powder-Free• Hand Specific | Similar | ||
| CharacteristicsandParameters | Subject Device | Predicate Device(K190018) | Discussion | ||
| • Beaded Cuff | • Beaded Cuff | ||||
| Sterility | Sterile | Sterile | Similar | ||
| Sterilization | Radiation10-6 SAL | Radiation10-6 SAL | Similar | ||
| Freedom fromholes | Meets ASTM D3577-19 requirements ofAQL 1.5 | Meets ASTM D3577-19 requirements ofAQL 1.5 | Similar | ||
| Length | Length (mm): ≥ 265 mm | Length (mm): ≥ 265 mm | Similar.Meets ASTMD3577-19 | ||
| Dimensions | 5.5: 70 ± 6 (mm)6.0: 76 ± 6 (mm)6.5: 83 ± 6 (mm)7.0: 89 ± 6 (mm)7.5: 95 ± 6 (mm)8.0: 102 ± 6 (mm)8.5: 108 ± 6 (mm)9.0: 114 ± 6 (mm) | 5.5: 70 ± 6 (mm)6.0: 76 ± 6 (mm)6.5: 83 ± 6 (mm)7.0: 89 ± 6 (mm)7.5: 95 ± 6 (mm)8.0: 102 ± 6 (mm)8.5: 108 ± 6 (mm)9.0: 114 ± 6 (mm) | Similar.Meets ASTMD3577-19 | ||
| Thickness | Cuff Thickness: ≥ 0.10 mmPalm Thickness: ≥ 0.10 mmFinger Thickness: ≥ 0.10 mm | Cuff Thickness: ≥ 0.10 mmPalm Thickness: ≥ 0.10 mmFinger Thickness: ≥ 0.10 mm | Similar.Meets ASTMD3577-19 | ||
| PhysicalProperties | Tensile Strength Before Aging: ≥ 17 MPaTensile Strength After Aging: ≥ 12 MPaUltimate Elongation Before Aging: ≥ 650 %Ultimate Elongation After Aging: ≥ 490 % | Tensile Strength Before Aging: ≥ 17 MPaTensile Strength After Aging: ≥ 12 MPaUltimate Elongation Before Aging: ≥ 650 %Ultimate Elongation After Aging: ≥ 490 % | Similar.Meets ASTMD3577-19 | ||
| Powder residual | Residual Powder: ≤ 2 mg per glove | Residual Powder: ≤ 2 mg per glove | Similar.Meets ASTMD3577-19 | ||
| In VitroCytotoxicityISO 10993-5 | Under the conditions of the study, the devicewas found to be cytotoxic | Under the conditions of the study, the devicewas found to be cytotoxic | Similar | ||
| Primary SkinIrritationISO 10993-10 | Under the conditions of the study, the deviceis not an irritant | Under the conditions of the study, the devicenot an irritant | Similar | ||
| DermalSensitizationISO 10993-10 | Under the conditions of the study, the deviceis not a sensitizer | Under the conditions of the study, the devicenot a sensitizer | Similar | ||
| Acute SystemicToxicityISO 10993-11 | Under the conditions of the study, therewas no evidence of systemic toxicity | Under the conditions of the study, therewas no evidence of systemic toxicity | Similar | ||
| PyrogenicityTestUSP <151> | Under the conditions of the study, the testarticle was non-pyrogenic | N/A | AdditionalPyrogenicityTest was testedon the subjectdevice | ||
| Test Methodology/Standards | Acceptance Criteria of theStandards | Result Summary | |||
| Size | Length(mm) | Width(mm) | |||
| DimensionsASTM D3577-19Standard Specification forRubber Surgical Gloves | 5.5 | Min 245 | 70 ± 6 | Meets ASTM D3577-19 requirements for lengthand width. Similar to predicate device. | |
| 6.0 | Min 265 | 76 ± 6 | |||
| 6.5 | Min 265 | 83 ± 6 | |||
| 7.0 | Min 265 | 89 ± 6 | |||
| 7.5 | Min 265 | 95 ± 6 | |||
| 8.0 | Min 265 | 102 ± 6 | |||
| 8.5 | Min 265 | 108 ± 6 | |||
| 9.0 | Min 265 | 114 ± 6 | |||
| Size | Average Length (mm) | ||||
| 5.5 | 285 | 74 | |||
| 6.0 | 283 | 80 | |||
| 6.5 | 290 | 84 | |||
| 7.0 | 290 | 91 | |||
| 7.5 | 292 | 98 | |||
| 8.0 | 300 | 103 | |||
| 8.5 | 297 | 109 | |||
| 9.0 | 291 | 116 | |||
| Meets ASTM D3577-19 requirements for thickness.Similar to predicate device | |||||
| Dimensions | Thickness (mm) | Size | Average Palm Thickness (mm) Min | Average Finger Thickness (mm) | Average Cuff Thickness (mm) |
| ASTM D3577-19Standard Specification forRubber Surgical Gloves | Palm Minimum 0.10Finger Minimum 0.10Cuff Minimum 0.10 | 5.5 | 0.21 | 0.23 | 0.15 |
| 6.0 | 0.20 | 0.23 | 0.16 | ||
| 6.5 | 0.20 | 0.23 | 0.16 | ||
| 7.0 | 0.19 | 0.23 | 0.15 | ||
| 7.5 | 0.20 | 0.24 | 0.15 | ||
| 8.0 | 0.19 | 0.23 | 0.15 | ||
| 8.5 | 0.20 | 0.24 | 0.16 | ||
| 9.0 | 0.20 | 0.24 | 0.15 | ||
| Physical PropertiesASTM D3577-19Standard Specification forRubber Surgical Gloves | Parameter | Before Aging | After Aging | Meets ASTM D3577-19 requirements for tensile strength and elongation at break before and after accelerated aging. Similar to predicate device. | |
| Tensile Strength | Min 17 MPa | Min 12 MPa | Before AgeTensile Strength (MPa)Average 17.9Elongation at Break (%)Average 952Stress at 500% Elongation (MPa)Average 2.2 | ||
| Ultimate Elongation | Min 650% | Min 490% | After AgeTensile Strength (MPa)Average 15.2Elongation at Break (%)Average 940 | ||
| Stress at 500% Elongation | Max 7.0 MPa | N/A | |||
| Freedom from holesASTM D5151-19Standard Test Method forDetection of Holes inMedical GlovesASTM D3577-19Standard Specification forRubber Surgical Gloves | AQL 1.5 | Meets ASTM D3577-19 and ASTM D5151-19 requirements of AQL 1.5. Similar to predicate device. | |||
| Powder residualASTM D6124-06(2017)Standard Test Method forResidual Powder onMedical GlovesASTM D3577-19Standard Specification forRubber Surgical Gloves | Powder Free; ≤ 2 mg per glove | Meets ASTM D3577-19 and ASTM D6124-06 (2017) requirements for Powder Free; ≤ 2 mg per glove. Similar to predicate device.Average 0.34 mg/glove | |||
| Chemotherapy DrugsPermeationASTM D6978-05(2019)Standard Practice forAssessment of Resistance ofMedical Gloves toPermeation byChemotherapy Drugs | Under the conditions of the study, no permeation. | See results in the Table above. |
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SUMMARY OF NON-CLINICAL TESTING:
Non-clinical testing was performed to verify that the subject device meets the acceptance criteria of the performance test and all design specifications. The test results demonstrated that the subject device with the following standards as shown below.
- . ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
- . ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves .
- . ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
- . ASTM F1929 -15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- . ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- . ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- ISO 10993-5 In Vitro Cytotoxicity .
- . ISO 10993-10 Primary Skin Irritation
- ISO 10993-10 Dermal Sensitization
- . ISO 10993-11 Acute Systemic Toxicity
- . USP <151> Pyrogen Test (USP Rabbit Test)
- . USP <85> Bacterial Endotoxins Test
Physical Characteristics
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| Pyrogenicity TestUSP <151> | Under the conditions of the study, thetest article was non-pyrogenic | Under the conditions of the study, the test article wasnon-pyrogenic |
|---|---|---|
| -------------------------------- | -------------------------------------------------------------------------- | -------------------------------------------------------------------------- |
Biocompatibility
| Test Methodology/Standards | Acceptance Criteria of theStandards | Result Summary |
|---|---|---|
| In Vitro CytotoxicityISO 10993-5:2009Biological evaluation ofmedical devices — Part 5:Tests for in vitrocytotoxicity | Under the conditions of the study, thedevice is not cytotoxic | Under the conditions of the study, the device wasfound to be cytotoxic and therefore the devicewere evaluated under ISO 10993-11 – Test for acutesystemic toxicity.From Acute Systemic Toxicity test, none of the testarticles were observed with signs of toxicity. Similarto predicate device |
| Primary Skin IrritationISO 10993-10:2010Biological evaluation ofmedical devices — Part 10:Tests for irritation and skinsensitization | Under the conditions of the study, thedevice is not an irritant | Under the conditions of the study, the device is notan irritant. Similar to predicate device |
| DermalSensitizationISO 10993-10:2021Biological evaluation ofmedical devices — Part 10:Tests for skin sensitization | Under the conditions of the study, thedevice is not a sensitizer | Under the conditions of the study, the device is nota sensitizer. Similar to predicate device |
| Acute SystemicToxicityISO 10993-11:2017Biological evaluation ofmedical devices —Part 11: Tests for systemictoxicity | Under the conditions of the study, thedevice does not pose a toxicityconcern | Under the conditions of the study, there was no signsof toxicity. Similar to predicate device |
CLINICAL PERFORMANCE DATA:
Not applicable. There was no clinical data required to support the subject device as the indication for use is equivalent to the predicate device.
CONCLUSION:
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).