(212 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient an examiner.
Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) Tested for use with Chemotherapy Drugs, meets all the current specifications listed under ASTM Specifications D6319-05 , Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05, Standard Practice for Assessment of Resistance to Permeation by Chemotherapy Drugs.
The provided document describes the acceptance criteria and performance of "Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) Tested for use with Chemotherapy Drugs" by YTY INDUSTRY (MANJUNG) SDN. BHD. This is a 510(k) premarket notification summary, demonstrating substantial equivalence to a predicate device (K101822).
The study primarily focuses on demonstrating that the gloves meet established industry standards and FDA requirements for patient examination gloves and resistance to chemotherapy drugs.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on ASTM D6319-10 (for examination gloves) and ASTM D6978-05 (for chemotherapy drug permeation), along with FDA 1000ml watertight test and powder content requirements. The reported device performance is for two colors: "Original Blue" and "Cobalt Blue."
| Test / Characteristic | Acceptance Criteria (Standard) | Original Blue Performance | Cobalt Blue Performance |
|---|---|---|---|
| Pinhole/Watertight | FDA 1000ml Water Leak Test, AQL = 2.5 (GI Multiple Normal) | Pass | Pass |
| Length (mm) | Min 230 (chemo claim min 270) | 273 - 278 (for M, L, XL sizes) | 276 - 278 (for M, L, XL sizes) |
| Palm Width (mm) | 95 ± 10 (for size M) | 97 - 99 (for size M) | 98 - 99 (for size M) |
| Thickness (mm) Single Layer | |||
| - Finger | Min 0.05 (chemo claim min 0.10) | 0.15 - 0.21 | 0.16 - 0.20 |
| - Palm | Min 0.05 (chemo claim min 0.10) | 0.11 - 0.12 | 0.11 - 0.12 |
| Physical Properties | |||
| - Before Aging: Tensile Strength (MPa) | Min 14 | 20.3 - 25.9 | 19.6 - 25.3 |
| - Before Aging: Ultimate Elongation (%) | Min 500 | 580 - 620 | 560 - 580 |
| - After Aging: Tensile Strength (MPa) | Min 14 | 26.5 - 35.6 | 25.0 - 28.4 |
| - After Aging: Ultimate Elongation (%) | Min 400 | 500 - 520 | 460 - 520 |
| Powder Content | Max 2.0 mg/glove | 0.34 mg/glove | 0.39 mg/glove |
| Moisture Content | Max 2.0% | 0.92% | 0.84% |
| Biocompatibility | Pass Primary Skin Irritation in Rabbits; Pass Guinea Pig Maximization | Yes (Pass) | Yes (Pass) |
| Chemotherapy Breakthrough (min) | (Breakthrough time varies by drug; generally >240 min desired for most drugs) | (See detailed table below) | (See detailed table below) |
Chemotherapy Breakthrough Detection Time (in minutes):
| TESTED CHEMOTHERAPY DRUG | Original Blue Average Breakthrough Detection Time (min) | Cobalt Blue Average Breakthrough Detection Time (min) |
|---|---|---|
| Carboplatin, 10 mg/ml | >240 | >240 |
| Carmustine (BCNU), 3.3 mg/ml | 1.84 | 1.82 |
| Cisplatin, 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 | >240 |
| Dacarbazine (DTIC), 10.0 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 | >240 |
| Etoposide (Toposar), 20.0 mg/ml | >240 | >240 |
| Fluorouracil, 50.0 mg/ml | >240 | >240 |
| Ifosfamide, 50.0 mgs/ml | >240 | >240 |
| Methotrexate, 25 mg/ml | >240 | >240 |
| Mitomycin C, 0.5 mg/ml | >240 | >240 |
| Mitoxantrone, 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 | >240 |
| Thiotepa, 10.0 mg/ml | 0.76 | 0.93 |
| Vincristine Sulfate, 1.0 mg/ml | >240 | >240 |
Note: Carmustine and Thiotepa show very low breakthrough times, and a warning is included in the labeling that these chemicals are not recommended for use with these gloves.
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., number of gloves for watertight test, number of gloves for physical properties, amount of chemotherapy testing). However, it implies testing according to ASTM standards, which would define appropriate sample sizes.
The data provenance is not explicitly stated as "retrospective" or "prospective" but represents testing conducted by the manufacturer (YTY INDUSTRY (MANJUNG) SDN. BHD.) for the purpose of this 510(k) submission. The company is located in Malaysia, suggesting the data originates from testing facilities associated with the manufacturer or their designated testing laboratories. Chemotherapy testing was performed by "ARDL CHEMICAL ANALYTICAL SERVICES."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission (for examination gloves) does not typically involve human experts establishing ground truth in the way it would for AI-driven diagnostic devices. The acceptance criteria are based on established industrial standards (ASTM) and regulatory requirements (FDA). The "ground truth" here is the pass/fail criteria defined by these standards for physical properties, barrier integrity, and chemical resistance. Expert involvement would be in interpreting these standards and overseeing the testing, rather than reaching a consensus on individual test outcomes.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" is determined by adherence to established, objective test methods and performance specifications from ASTM standards and FDA requirements. There isn't a subjective assessment that requires adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a physical product (examination gloves), not an AI-driven diagnostic or interpretative system. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used is based on:
- Industry Standards: ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) and ASTM D6978-05 (Standard Practice for Assessment of Resistance to Permeation by Chemotherapy Drugs).
- Regulatory Requirements: FDA 1000ml watertight test criteria and specific powder content limits.
- Biocompatibility Testing: Standards for primary skin irritation and sensitization tests.
These standards provide objective, measurable criteria for the performance of the gloves.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device. The physical properties and chemical resistance are inherent to the product's design and manufacturing process, and performance is evaluated against defined standards, not through machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The "ground truth" for the performance evaluation is established by the accepted and universally applied methods and specifications outlined in the ASTM standards and FDA guidelines.
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YTY INDUSTRY (MANJUNG) SDN. BHD.
(Company No : 380830-P) Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Tel : 05-6792288 (Hunting Line), 6792443 & 6792445 Fax : 05-6791188
DEC - 1 2011
| 2 | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|---|---|---|---|
510 (K) SUMMARY SHEETS
| 1.0 | SMDA 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | YTY INDUSTRY (MANJUNG) SDN. BHD.,Lot 1422-1424, Batu 10 Lekir32020 Sitiawan, PerakMalaysia |
| Tel | 605-6792288 | |
| Fax | 605-6791188 | |
| Name of Contact Person | 1. Mr. Roger Moh Ung Nang2. Mr. Arivalagan | |
| Date of Summary Prepared | November 1, 2010 | |
| 3.0 | Name of Device | |
| Trade Name: | Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) Tested for use with Chemotherapy Drugs. | |
| Common Name: | Synthetic Rubber Examination Gloves |
Classification Name: Patient Examination Glove, Powder Free
Identification of The Legally Marketed Devices 4.0
The legally marketed device to which we claim substantial equivalence is K101822, Blue Nitrile Examination Gloves, Tested for Use With Chemotherapy Drugs Labeling Claim, (Non-Sterle), which is a Class 1 device with Product Codes LZA/LZC. The predicate device was approved Nov 19, 2010, Except for the color differences, and some different chemotherapy chemicals broakthroughtesting times, we do claim this submission is essentially equivalent.
5.0 Description of The Device
Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) Tested for use with Chemotherapy Drugs, meets all the current specifications listed under ASTM Specifications D6319-05 , Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05, Standard Practice for Assessment of Resistance to Permeation by Chemotherapy Drugs.
Page 1 of 1
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6.0 The Intended Use of Glove
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.
Summary of Performance Data: 7.0
| Performance data of gloves based on ASTM D6319-10 and FDA 1000ML watertight test. | |||
|---|---|---|---|
| Test | FDA 1000ml Water LeakTest | Powder Free NitrileExamination Gloves | |
| Multiple Normal | Original Blue | Cobalt Blue | |
| 1. Watertight (1000ml) | GIAQL = 2.5 | Pass | Pass |
| Test | ASTM D6319-10 | ||
| 2. Length (mm)SizeMLXL | Min 230 (chemo claim min 270)Min 230 (chemo claim min 270) | 273 - 278 | 276 - 278 |
| 3. Palm width (mm)SizeM | 95 ± 10 | 97 - 99 | 98 - 99 |
| 4. Thickness (mm)(Single Layer) | |||
| Finger | Min 0.05 (chemo claim min0.10) | 0.15-0.21 | 0.16-0.20 |
| Palm | Min 0.05 (chemo claim min0.10) | 0.11-0.12 | 0.11-0.12 |
| 5. Physical Properties | |||
| Before Aging | |||
| Tensile Strength (MPa) | Min 14 | 20.3 - 25.9 | 19.6 - 25.3 |
| Ultimate Elongation (%) | Min 500 | 580 - 620 | 560 - 580 |
| After Aging | |||
| Tensile Strength (MPa) | Min 14 | 26.5 - 35.6 | 25.0 - 28.4 |
| Ultimate Elongation (%) | Min 400 | 500 - 520 | 460 - 520 |
| 6. Powder Content | Max 2.0mg/glove | 0.34 mg/glove | 0.39 mg/glove |
| 7. Moisture Content | Max 2.0% | 0.92% | 0.84% |
Page 2 of 4
510 (k) Summary
Page 2 of 4 revised 10-20-2011
Joanna Rucker
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SUBSTANTIAL EQUIVALENCE COMPARISONS
12111248
| TESTED PERFORMANCE DATA FOR BLUE | SGMP K101822 | ||
|---|---|---|---|
| YTY POWDER FREE NITRILE EXAM GLOVES | BLUE NITRILE | ||
| WITH CHEMO DRUG LABELING CLAIMS | CHEMO TESTED | ||
| ASTM D6319-05 NITRILE SPECIFICATION | |||
| ORIGINAL | COBALT | K101822 | |
| FDA 1000ML Water Tight AOL | 2.5 | 2.5 | 2.5 |
| Length (mm) | 244-249 | 247-250 | 295 |
| Width (mm) | 97-99 | 98-99 | 95 |
| Thickness (mm) | |||
| Finger: | 0.12 - 0.14 | 0.12 - 0.13 | 0.18 - 0.21 |
| Palm: | 0.06 - 0.07 | 0.07 - 0.08 | 0.16-0.19 |
| Tensile Strength (Mpa) | |||
| Before Aging | 17.8 - 20.0 | 23/0 - 27.0 | 14 |
| After Aging | 21.3 - 23.6 | 30.2 - 34.6 | 14 |
| Ultimate Elongation (%) | |||
| Before Aging | 680 - 720 | 660 - 680 | 500 |
| After Aging | 600 - 620 | 560 - 580 | 400 |
| Finished Total Powder Level (mg/glove | 0.48 | 0.22 | <2.0 |
| Biocompatibility Testing (CPTC) | |||
| Pass Primary Skin Irritation in Rabbits | Yes | Yes | Yes |
| Pass Guinea Pig Maximization | Yes | Yes | Yes |
| CHEMOTHERAPY TESTING BY ARDL CHEMICAL ANALYTICAL SERVICES | |||
| Minimum Breakthrough Detection Time in Minutes: | |||
| Carboplatin, 10 mg/ml | >240 | >240 | Not tested |
| Carmustine (BCNU), 3.3 mg ml | 1.84 | 1.82 | 0.49 |
| Cisplatin, 1.0 mg/ml | >240 | >240 | >240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 | >240 | >240 |
| Dacarbazine (DTIC), 10.0 mg/ml | >240 | >240 | >240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 | >240 | >240 |
| Etoposide (Toposar), 20.0 mg/ml | >240 | >240 | >240 |
| Fluorouracil, 50.0 mg/ml | >240 | >240 | >240 |
| Ifosfamide, 50,0 mgs/ml | >240 | >240 | Not tested |
| Methotrexate, 25 mg/ml | >240 | >240 | >240 |
| Mitomycin C. 0.5 mg/ml | >240 | >240 | Not tested |
| Mitoxantrone, 2 mg/ml | >240 | >240 | Not tested |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 | >240 | >240 |
| Thiotepa, 10.0 mg/ml | 0.76 | 0.93 | 2.61 |
| Vincristine Sulfate, 1.0 mg/ml | >240 | >240 | >240 |
- WARNING: DO NOT USE WITH CARMUSTINE OR THIOTEPA´ is included as warnings on all three products (YTY and SGMP labeling claims)
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- The performance data of the glove as shown above meet the ASTM D6319-05 8.0 Standard and FDA's requirement. Standard and I DA 3 requirement.
Powder content is below 2 mg per glove which meet the FDA Requirements. - The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig 9.0 Sensitization (Buehler) test. For both colors The gloves pass the Bio-compatibility Test.
- Conclusion 10.0
.
- We conclude that the Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, We Concided that the Non Sterth, Chemotherapy Drugs does meet:
- ASTM D6319-05 Standard
- FDA pinhole requirements -
- PDA philose requirements
Are below the maximum Powder Residual Content as specified in ASTM -D6319-02- ASTM D5151 (which equates to the FDA Water Leak Test) -
- ASTM D6978-05 (Chemotherapy Testing Standards)
Page
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes, possibly representing human figures or waves, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC = 1 2011
YTY Industry (Manjung) Sdn. Bhd. C/O Ms. Janna P. Tucker Consultant Tucker & Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434
Re: K111248
Trade/Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves (Original Blue, Cobalt Blue). Tested for Use with The Below Chemotherapy Drugs
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA, LZC Dated: November 10, 2011 Received: November 21, 2011
Dear Ms. Tucker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Tucker
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices /Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D, man
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
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INDICATIONS FOR USE
| APPLICANT: | YTY INDUSTRY (MANJUNG) SDN BHD |
|---|---|
| 510(K) NUMBER: | K111248 |
| DEVICE NAME: | Non-Sterile, Powder Free Nitrile Examination Gloves |
Non-Sterile, Powder Free Nitrile Examination Gloves (Original Blue, Cobalt Blue). Tested for use with the below chemotherapy drugs.
INDICATIONS FOR USE:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient an examiner.
Chemotherapy Drug Permeation (breakthrough detection time) in minutes. The following chemicals have been tested with these gloves:
| TESTED CHEMOTHERAPY DRUG | Original Blue AverageBreakthrough DetectionTime in Minutes | Original Blue AverageBreakthrough DetectionTime in Minutes |
|---|---|---|
| Carboplatin, 10 mg/ml | >240 | >240 |
| Carmustine (BCNU), 3.3 mg/ml) | **1.84 | **1.82 |
| Cisplatin, 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 | >240 |
| Dacarbazine (DTIC), 10.0 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20.0 mg/ml | >240 | >240 |
| Fluorouracil, 50.0 mg/ml | >240 | >240 |
| Ifosfamide, 50.0 mg/ml | >240 | >240 |
| Methotrexate, 25 mg/ml | >240 | >240 |
| Mitomycin C, 0.5 mg/ml | >240 | >240 |
| Mitoxantrone, 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 | >240 |
| Thiotepa, 10.0 mg/ml | **0.76 | **0.93 |
| Vincristine Sulfate, 1.0 mg/ml | >240 | >240 |
** Please note that Carmustine (BCNU)and Thiotepa have extremely low permeation times for both glove colors. These two chemicals are not recommended for use with either color of the gloves.
Prescription Use
(Part 21 CFR 801.Subpart D
and/or
Over-The-Counter
21 CFR 801.Subpart C
Concurrence of CDRH, Office of Device Evaluation (ODE)
Adhip Ganguly
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
-10(k) Number: K111248
§ 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.