(102 days)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl Citrate.
Powder Free Polyisoprene Surgical Glove, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance meets all the requirements of ASTM standard D3577, ASTM D6978-05 and FDA 21 CFR 878.4460. The powder free polyisoprene surgical glove is manufactured from 100% synthetic polyisoprene latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of qlove, i.e., tensile strength meets ASTM standard D3577. Device is intended for single use. The powder free polyisoprene surgical glove, sterile is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9. This glove comes in natural color and powder free.
The provided text describes the acceptance criteria and performance data for a medical device (Polyisoprene Surgical Glove) in the context of an FDA 510(k) submission. It focuses on the device's physical properties, safety (biocompatibility), and resistance to chemotherapy drugs and fentanyl. This is a medical device, not an AI/ML device, so many of the requested elements for AI/ML performance studies (e.g., sample size for test/training sets, expert ground truth, MRMC studies, effect size, etc.) are not applicable or present in this document.
However, I can extract the acceptance criteria and device performance based on the non-clinical testing sections provided.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document provides extensive tables (Table 1, starting on page 7, and the "Summary of Non-Clinical Testing" tables starting on page 16) detailing the characteristics, standards, acceptance criteria, and device performance. I will consolidate the key acceptance criteria and reported performance from these tables.
| Characteristic | Standard/Purpose of Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties | ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers - Tension) | Before Aging: Min. 17MPa (Tensile Strength), Min. 650% (Ultimate Elongation), Max. 7.0MPa (Stress at 500% Elongation) | Pass (Meets criteria) |
| After Aging: Min. 12MPa (Tensile Strength), Min. 490% (Ultimate Elongation), N/A (Stress at 500% Elongation) | Pass (Meets criteria) | ||
| Dimension (Length) | ASTM D3767 (Standard Practice for Rubber - Measurement of Dimensions) | Varies by size (e.g., 5½: Min. 245 mm, 6.0: Min. 265 mm, etc.) | Pass for all sizes (Meets criteria) |
| Dimension (Width) | ASTM D3767 (Standard Practice for Rubber - Measurement of Dimensions) | Varies by size (e.g., 5½: 70 ± 6 mm, 6.0: 76 ± 6 mm, etc.) | Pass for all sizes (Meets criteria) |
| Dimension (Thickness) | ASTM D3767 (Standard Practice for Rubber - Measurement of Dimensions) | Finger: Min. 0.10 mm, Palm: Min. 0.10 mm, Cuff: Min. 0.10 mm | Pass for all (Meets criteria) |
| Watertight | ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves) | Sample size: 125 pcs, Inspection level: GI, AQL: 0.65, Acceptance No. 2, Found 1 | Pass (Found 1, which is within the AQL of 0.65) |
| Residual Powder | ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) | Have a powder residue limit of 2.0 mg per glove | Pass (Meets ≤ 2.0 mg/glove) |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10 (E) & Consumer Product Safety Commission Title 16, Chapter II, Part 1500 | Not a primary skin irritation | Pass (Not a primary skin irritant) |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10 (E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3 (c) (4) | Not a contact sensitizer | Pass (Not a contact sensitizer) |
| Biocompatibility (Acute Systemic Toxicity) | ISO 10993-11 (E) | No biological reactivity shown | Pass (Concluded that the product did not induce any systemic toxicity) |
| Biocompatibility (Material Mediated Pyrogenicity) | ISO 10993-11 (E) | No increase of temperature | Pass (Concluded that the product is considered to be non-pyrogenic) |
| Chemotherapy Drug Permeation | ASTM D6978 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs) | Varies by drug (e.g., Cisplatin: > 240 mins, Carmustine: 24.0 mins, ThioTepa: 23.1 mins) | Reported specific breakthrough times, meeting or exceeding expectations for most drugs. Warnings issued for drugs with low permeation times. |
| Fentanyl Resistance | ASTM D6978 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs) | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set:
- For the Watertight test (ASTM D5151), the sample size was 125 pieces.
- For other physical and material tests (e.g., Physical Properties, Dimension, Residual Powder, Biocompatibility), specific sample sizes are not explicitly stated in the provided text, but testing standards (e.g., ASTM D412, D3767, D6124, ISO 10993 series) would prescribe minimum sample sizes for these tests.
- For Chemotherapy Drug and Fentanyl Permeation, the ASTM D6978 standard would specify the number of samples required, but this is not detailed in the document.
- Data Provenance: The testing was conducted as part of a 510(k) submission for a device manufactured by WRP Asia Pacific Sdn. Bhd. (Malaysia). The tests themselves are non-clinical, laboratory-based tests adhering to international and ASTM standards. The data is thus prospective, generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a medical device (glove) filing, not an AI/ML device requiring human expert annotation or ground truth establishment in the traditional sense. The "ground truth" for the device's performance is established by the results of standardized physical, chemical, and biological tests, not by human expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is not an AI/ML study involving human interpretation of data where adjudication is needed, no such method was employed. The results are quantitative measurements against established test standards.
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:
- No. This is not an AI/ML device, and no MRMC comparative effectiveness study was performed. The device is a physical barrier (surgical glove).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical product (glove), not an algorithm or AI. Its performance is inherent to its material and manufacturing, tested against physical and chemical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on objective measurements and chemical/physical analyses performed according to established and recognized international standards (ASTM, ISO). For example:
- Tensile strength (measured in MPa, physical property).
- Elongation (measured in %, physical property).
- Dimensions (measured in mm, physical property).
- Detection of holes (binary, based on water leakage).
- Residual powder (measured in mg/glove, chemical analysis).
- Permeation breakthrough time (measured in minutes, chemical analysis).
- Biocompatibility tests (evaluating biological reactions based on validated assays).
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
October 22, 2022
WRP Asia Pacific SDN. BHD. % Michael Scaglione U.S. Agent WRP USA Inc 3700 Massillon Road Suite 340 Uniontown, Ohio 44685
Re: K222058
Trade/Device Name: Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I. reserved Product Code: KGO, LZC, OPJ, QDO Dated: July 6, 2022 Received: July 12, 2022
Dear Michael Scaglione:
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,
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
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Indications for Use
510(k) Number (if known) K222058
Device Name
POLYISOPRENE SURGICAL GLOVE, POWDER FREE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL RESISTANCE
Indications for Use (Describe)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug | Concentration Average Breakthrough Detection Time (Minutes) |
|---|---|
| *Carmustine (BCNU) (3.3 mg/ml) | 24.0 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (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 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| *ThioTepa (10.0 mg/ml) | 23.1 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 24.0 minutes and Thiotepa: 23.1. Do not use with Carmustine and Thiotepa
| Fentanyl Resistance | Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100mcg/2mL) | No breakthrough up to 240 minutes |
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) |
|---|---|
| ----------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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K222058
1.0 Submitter:
| Name | : Saravanan Ramasamy |
|---|---|
| Address | : WRP Asia Pacific Sdn. Bhd.Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru SalakTinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No. | : +60 3 8706 1486 |
| Fax No. | : +60 3 8706 1557 |
| Date of SummaryPrepared | : 10/20/2022 |
2.0 Identification of the subject device:
| Trade Name | : Polyisoprene Surgical Glove, Powder Free, Sterile,Tested for Use with Chemotherapy Drugs and FentanyResistance |
|---|---|
| Common Name | : Surgical Gloves |
| Classification Name | : Surgeon's Gloves |
| Device Classification | : I |
| Regulation Number | : 21 CFR 878.4460 |
| Product Code | : KGO, LZC, OPJ, QDO |
3.0 Predicate Device:
| Predicate | |
|---|---|
| Manufacturer | WRP Asia Pacific Sdn. Bhd. |
| Device name | Powder Free Polymer Coated PolyisopreneSurgical Glove, Sterile |
| 510(k) Number | K032942 |
| Regulatory Class | I |
| Product Code | KGO |
4.0 Reference Device:
| Reference | |
|---|---|
| Manufacturer | WRP Asia Pacific Sdn. Bhd. |
| Device name | Powder Free Nitrile Surgical Glove, Sterile, Testedfor Use with Chemotherapy Drugs |
| 510(k) Number | K203030 |
| Regulatory Class | I |
| Product Code | KGO, LZC |
{5}------------------------------------------------
Description of The Device: 5.0
Powder Free Polyisoprene Surgical Glove, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance meets all the requirements of ASTM standard D3577, ASTM D6978-05 and FDA 21 CFR 878.4460.
The powder free polyisoprene surgical glove is manufactured from 100% synthetic polyisoprene latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of qlove, i.e., tensile strength meets ASTM standard D3577. Device is intended for single use.
The powder free polyisoprene surgical glove, sterile is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9. This glove comes in natural color and powder free.
6.0 Indication for use:
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug PermeationThe following chemicals have been tested with these gloves. | ||
|---|---|---|
| Chemotherapy Drug | Concentration | BreakthroughDetection Time(Minutes) |
| *Carmustine (BCNU) | 3.3 mg/ml | 24.0 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 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 |
| Ifosfamide | 50.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |
{6}------------------------------------------------
| Mitoxantrone | 2.0 mg/ml | > 240 |
|---|---|---|
| Paclitaxel | 6.0 mg/ml | > 240 |
| *ThioTepa | 10.0 mg/ml | 23.1 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |
*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 24.0 and ThioTepa: 23.1. Do not use with Carmustine and Thiotepa.
| Fentanyl Resistant | Concentration | Breakthrough DetectionTime in Minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240minutes |
7.0 Summary of the Technological Characteristics of the Device:
The Powder Free Polyisoprene Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs and Fentanyl Resistance are summarized with the following technological characteristics compared to ASTM D3577 or equivalent standards as shown in Table 1.
{7}------------------------------------------------
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | ||
|---|---|---|---|---|---|
| PREDICATE | REFERENCE | CURRENT | |||
| 510(k) Number | - | K032942 | K203030 | K222058 | - |
| Manufacturer(s) | - | WRP Asia Pacific Sdn. Bhd. | WRP Asia Pacific Sdn. Bhd. | WRP Asia Pacific Sdn. Bhd. | Same |
| Material | ASTM D3577 | Polyisoprene Rubber | Nitrile | Polyisoprene Rubber | Different |
| Color | - | Cream | Natural | Natural White | Different |
| Texture | - | Micro roughened | Bisque Finish | Bisque Finish | Different |
| Physical Properties | ASTM D3577 | Meets | Meets | Meets | Same |
| Before AgingTensile Strength:UltimateElongation:Stress at 500%Elongation:After AgingTensile Strength:UltimateElongation:Stress at 500%Elongation: | Min. 17MPaMin. 650%Max. 7.0MPaMeetsMin. 12MPaMin. 490%N/A | Meets | Min. 17MPaMin. 650%Max. 7.0MPaMeetsMin. 12MPaMin. 490%N/A | Same |
{8}------------------------------------------------
| STANDARDS | DEVICE PERFORMANCE | |||||
|---|---|---|---|---|---|---|
| CHARACTERISTICS | PREDICATE | REFERENCE | CURRENT | COMPARISON ANALYSIS | ||
| 510(k) Number | - | K032942 | K203030 | K222058 | ||
| Thickness: | ASTM D3577 | Meets | Meets | Meets | Same | |
| - Finger- Palm- Cuff | Min. 0.10 mmMin. 0.10 mmMin. 0.10 mm | Min. 0.10 mm | Min. 0.10 mmMin. 0.10 mmMin. 0.10 mm | |||
| Dimension, | ASTM D3577 | Meets | Meets | Meets | Same | |
| Length | 5½: Min. 245mm | 5½: Min. 245 mm | 5½: Min. 245 mm | |||
| 6.0: Min. 265 mm | 6.0: Min. 265 mm | 6.0: Min. 265 mm | ||||
| 6½: Min. 265 mm | 6½: Min. 265 mm | 6½: Min. 265 mm | ||||
| 7.0: Min. 265 mm | 7.0: Min. 265 mm | 7.0: Min. 265 mm | ||||
| 7½: Min. 265 mm | 7½: Min. 265 mm | 7½: Min. 265 mm | ||||
| 8.0: Min. 265 mm | 8.0: Min. 265 mm | 8.0: Min. 265 mm | ||||
| 8½: Min. 265 mm | 8½: Min. 265 mm | 8½: Min. 265 mm | ||||
| 9.0: Min. 265 mm | 9.0: Min. 265 mm | 9.0: Min. 265 mm | ||||
| Dimension, Width | ASTM D3577 | Meets | Meets | Meets | Same | |
| 5½: 70 ± 6 mm | 5½: 70 ± 6 mm | 5½: 70 ± 6 mm | ||||
| 6.0: 76 ± 6 mm | 6.0: 76 ± 6 mm | 6.0: 76 ± 6 mm | ||||
| 6½: 83 ± 6 mm | 6½: 83 ± 6 mm | 6½: 83 ± 6 mm | ||||
| 7.0: 89 ± 6 mm | 7.0: 89 ± 6 mm | 7.0: 89 ± 6 mm | ||||
| 7½: 95 ± 6 mm | 7½: 95 ± 6 mm | 7½: 95 ± 6 mm | ||||
| 8.0: 102 ± 6 mm | 8.0: 102 ± 6 mm | 8.0: 102 ± 6 mm | ||||
| 8½: 108 ± 6 mm | 8½: 108 ± 6 mm | 8½: 108 ± 6 mm | ||||
| 9.0: 114 ± 6 mm | 9.0: 114 ± 6 mm | 9.0: 114 ± 6 mm | ||||
| STANDARDS | DEVICE PERFORMANCE | |||||
| CHARACTERISTICS | PREDICATE | REFERENCE | CURRENT | COMPARISON ANALYSIS | ||
| 510(k) Number | K032942 | K203030 | K222058 | |||
| Powder Free | ASTM D6124 | Meetsrequirements of≤2.0 mg/glovefor Powder-Freedesignation perASTM D3577 | Meetsrequirements of≤2.0 mg/glovefor Powder-Freedesignation perASTM D3577 | Meetsrequirements of≤2.0 mg/glovefor Powder-Freedesignation perASTM D3577 | Same | |
| Biocompatibility | Primary SkinIrritation -ISO 10993-10 (E) &ConsumerProductSafetyCommissionTitle 16,Chapter II,Part 1500 | Passes (Not aprimary skinirritant). | Passes (Not aprimary skinirritant). | Passes (Not aprimary skinirritant). | Similar | |
| DermalSensitization- ISO10993-10(E) &ConsumerProductSafetyCommission,Title 16,Chapter II,Part 1500.3(c) (4) | Passes (Not acontact sensitizer). | Passes (Not acontactsensitizer). | Passes (Not acontactsensitizer). | Similar | ||
| CHARACTERISTICS | STANDARDS | PREDICATE | DEVICE PERFORMANCE | REFERENCE | CURRENT | COMPARISON ANALYSIS |
| 510(k) Number | - | K032942 | K203030 | K222058 | - | |
| AcuteSystemicToxicity, ISO10993-11(E) | N/a | It is concludedthat the productdid not induceany systemictoxicity | It is concludedthat the productdid not induceany systemictoxicity | Different | ||
| MaterialMediatedPyrogenicity,ISO 10993-11 (E) | N/a | It is concludedthat the productis considered tobe non-pyrogenic | It is concludedthat the productis considered tobe non-pyrogenic | Different | ||
| Watertight(1000ml) | ASTM D5151 | Meets 21 CFR800.20 andASTM D3577 whentested inaccordance withASTM D5151Inspection Level 1,AQL 1.5. | Meets 21 CFR800.20 and ASTMD3577 whentested inaccordance withASTM D5151Inspection LevelI, AQL 0.65 | Meets 21 CFR800.20 and ASTMD3577 whentested inaccordance withASTM D5151Inspection LevelI, AQL 0.65 | Similar (AQL was subsequentlylowered after FDA cleared thepredicate) | |
| Intended use /Indications for Use | - | A powder free,polymer coatedpolyisoprenesurgical glove,sterile, is made ofsynthetic rubberlatex and intendedto be worn on thehand of healthcarepersonnel | A powder-freesterile surgeon'sglove is adisposable devicemade of syntheticrubber intendedto be worn on thehands ofhealthcarepersonnel as a | A powder-freesterile surgeon'sglove is adisposable devicemade of syntheticrubber intendedto be worn on thehands ofhealthcarepersonnel as a | Same with additional characteristics. | |
| CHARACTERISTICS | STANDARDS | PREDICATE | DEVICE PERFORMANCEREFERENCE | CURRENT | COMPARISON ANALYSIS | |
| 510(k) Number | - | K032942 | K203030 | K222058 | - | |
| operating roompersonnel andsimilar personnelto preventcontaminationbetween thehealthcare orsimilar personneland the patient'sbody, fluids,waste, orenvironment. | barrier forprotection againstcross-contaminationbetween thehealthcarepersonnel andpatient.These gloveswere tested foruse withchemotherapydrugs inaccordance withASTM D6978-05Standard Practicefor Assessment ofMedical Gloves toPermeation byChemotherapyDrugs. | barrier forprotection againstcross-contaminationbetween thehealthcarepersonnel andpatient.These gloveswere tested foruse withChemotherapyDrugs andFentanyl Citrateas per ASTMD6978 StandardPractice forAssessment ofMedical Gloves toPermeation byChemotherapyDrugs | ||||
| CHARACTERISTICS | STANDARDS | PREDICATE | REFERENCE | CURRENT | COMPARISON ANALYSIS | |
| 510(k) Number | - | K032942 | K203030 | K222058 | - | |
| Size | MedicalGloveGuidanceManual -Labeling | 5½6.06½7.07½8.08½9.0 | 5½6.06½7.07½8.08½9.0 | 5½6.06½7.07½8.08½9.0 | Same | |
| Single Use | MedicalGloveGuidanceManual -Labeling | Single use | Single use | Single use | Same | |
| Sterility Status | MedicalGloveGuidanceManual -Labeling | Sterile | Sterile | Sterile | Same | |
| Sterility Method | ISO 11137-1ISO 11137-2 | Gamma Radiation | Gamma Radiation | Gamma Radiation | Same | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |||
| PREDICATE | REFERENCE | CURRENT | ||||
| 510(k) Number | K032942 | K203030 | K222058 | - | ||
| ChemotherapyDrug PermeationTest | ASTMD6978-05 | Minimum Breakthrough Detection Time (Minutes) | ||||
| * Carmustine (BCNU)(3.3 mg/ml) | N/A | 27.3 | 24.0 | Different | ||
| Cisplatin (1.0 mg/ml) | N/A | > 240 | > 240 | Different | ||
| Cyclophosphamide(Cytoxan) (20.0mg/ml) | N/A | > 240 | > 240 | Different | ||
| Dacarbazine (10.0mg/ml) | N/A | > 240 | > 240 | Different | ||
| DoxorubicinHydrochloride (2.0mg/ml) | N/A | > 240 | > 240 | Different | ||
| Etoposide (20.0mg/ml) | N/A | > 240 | > 240 | Different | ||
| Fluorouracil (50.0mg/ml) | N/A | > 240 | > 240 | Different | ||
| Ifosfamide (50.0mg/ml) | N/A | > 240 | > 240 | Different | ||
| Methotrexate (25.0mg/ml) | N/A | > 240 | > 240 | Different | ||
| Mitomycin C (0.5mg/ml) | N/A | > 240 | > 240 | Different | ||
| Mitoxantrone (2.0mg/ml) | N/A | > 240 | > 240 | Different | ||
| Paclitaxel (6.0mg/ml) | N/A | > 240 | > 240 | Different | ||
| CHARACTERISTICS | STANDARD S | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |||
| PREDICATE | REFERENCE | CURRENT | ||||
| 510(k) Number | - | K032942 | K203030 | K222058 | - | |
| * ThioTepa (10.0 mg/ml) | N/A | 26.9 | 23.1 | Different | ||
| Vincristine Sulfate (1.0 mg/ml) | N/A | > 240 | > 240 | Different | ||
| Warning Statement | N/A | CAUTION: Testing showed an average breakthrough time of 27.3 minutes for Carmustine and an average breakthrough time of 26.9 minutes for ThioTepa | WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 24.0 minutes and Thiotepa: 23.1. Do not use with Carmustine and Thiotepa | Different | ||
| Fentanyl Resistant | ASTM D6978-05 | N/A | N/A | > 240 | Different |
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WRP Summary, Page 10 of 17
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There are no significant differences between the devices and are identical in terms of intended use, material, color and size. Both devices meet the applicable requirements for surgical gloves regarding physical properties, freedom from holes, and powder residues.
Unlike the predicate, the current device has been tested for Acute Systemic Toxicity and for use with Chemotherapy Drugs and Fentanyl Citrate in accordance to ASTM D6978-05, which is a recognized attribute claim in FDA's Glove Guidance Manual and in other cleared surgical gloves, such as K203030 which is included are a reference.
8.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical test for this Powder Free Polyisoprene Surgical Glove, Sterile is summarized as per below.
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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | |||
|---|---|---|---|---|---|---|---|
| BeforeAging | AfterAging | BeforeAging | AfterAging | ||||
| PhysicalProperties | ASTM D412(Standard TestMethod forVulcanized Rubberand ThermoplasticElastomers -Tension) | To evaluate thetensile (tension)properties of glove | TensilestrengthUltimateelongationStress at500%Elongation | Min.17MPaMin.650%Max.7.0MPa | Min.12MPaMin.490%N/A | PassPassPass | PassPassN/A |
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| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimension | ASTM D3767(Standard Practicefor Rubber -Measurement ofDimensions) | To measure thelength, width andthickness of glove | Length 5½ - Min. 245 mm | Pass |
| 6.0 - Min. 265 mm | Pass | |||
| 6½ - Min. 265 mm | Pass | |||
| 7.0 - Min. 265 mm | Pass | |||
| 7½ - Min. 265 mm | Pass | |||
| 8.0 - Min. 265 mm | Pass | |||
| 8½ - Min. 265 mm | Pass | |||
| 9.0 - Min. 265 mm | Pass | |||
| Width 5½ - 70 ± 6 mm | Pass | |||
| 6.0 - 76 ± 6 mm | Pass | |||
| 6½ - 83 ± 6 mm | Pass | |||
| 7.0 - 89 ± 6 mm | Pass | |||
| 7½ - 95 ± 6 mm | Pass | |||
| 8.0 - 102 ± 6 mm | Pass | |||
| 8½ - 108 ± 6 mm | Pass | |||
| 9.0 - 114 ± 6 mm | Pass | |||
| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results |
| Dimension | ASTM D3767(Standard Practicefor Rubber -Measurement ofDimensions) | To measure thelength, width andthickness of glove | Thickness Finger - Min. 0.10 mm | Pass |
| Palm - Min. 0.10 mm | Pass | |||
| Cuff - Min. 0.10 mm | Pass |
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| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results |
|---|---|---|---|---|
| Watertight | ASTM D5151(Standard TestMethod forDetection of Holesin Medical Gloves) | To detect holes thatleak water andthereby compromisethe usefulness of theglove | Sample size: 125 pcsInspection level: GIAQL:0.65, Acceptance No.2, Found 1 | Pass |
| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results |
|---|---|---|---|---|
| ResidualPowder | ASTM D6124(Standard TestMethod for ResidualPowder on MedicalGloves) | To determine theamount of residualpowder and non-powder solids foundon gloves | Have a powder residue limitof 2.0 mg per glove | Pass |
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| Test Method | Standard | Purpose ofTesting | Acceptance Criteria | Results |
|---|---|---|---|---|
| Biocompatibility | Primary SkinIrritation - ISO10993-10 (E) &Consumer ProductSafety CommissionTitle 16, ChapterII, Part 1500 | To assess thepotential of glove toproduce dermalirritation | Not a primary skinirritation | Pass |
| Biocompatibility | DermalSensitization- ISO10993-10 (E) &Consumer ProductSafetyCommission, Title16, Chapter II, Part1500.3 (c) (4) | To assess thepotential of glove tocause a delayedhypersensitivity(Type IV)immunologicalresponse | Not a contact sensitizer | Pass |
| Biocompatibility | Acute SystemicToxicity, ISO10993-11 (E) | To determine theacute systemictoxicity potential ofglove | No biological reactivityshown | Pass |
| Biocompatibility | Material MediatedPyrogenicity, ISO10993-11 (E) | To determine anypyrogenic responseinduced by theglove | No increase oftemperature | Pass |
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8.0 Summary of Clinical Testing:
No clinical study is included in this submission.
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance is as safe, as effective, and performs as well as or better than the legally marketed predicate device K032942.
§ 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).