(100 days)
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
These gloves are tested for use with Chemotherapy Drugs.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21CFR 880.6250, Patient Examination Glove 80 LZA, and meets all requirements of ASTM Standard D6319-00a e3
Here's a summary of the acceptance criteria and the study details for the Dynarex / Tillotson Nitrile Powder Free Blue Patient Examination Glove:
1. Acceptance Criteria and Reported Device Performance:
The device's performance is primarily assessed against the requirements of ASTM Standard D6319-00a £3 (later referenced as ASTM D6319-00ae3-2001) for patient examination gloves and specific permeation testing for chemotherapy drugs per ASTM D 6978-05. The table below combines the acceptance criteria (implied by the ASTM standards and "Passes" results) with the reported device performance.
| Characteristic / Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material/Construction | Nitrile, Powder-Free | Nitrile, Powder-Free |
| Dermal Sensitization Test | Passes (no sensitization) | Passes |
| Primary Skin Irritation Test | Passes (no primary irritation) | Passes |
| Permeation testing per ASTM D 6978-05 (Chemotherapy Drugs) | Passes (meets specific permeation limits for chemotherapy drugs) | Passes |
| Water Leak Test (Pinholes) | AQL 2.5 (ASTM D6319-00ae3) | Passes (meets requirements of ASTM D6319-00ae3), AQL 2.5 pinholes |
| Dimensions (Length) | Meets requirements of ASTM D6319-00ae3 | Meets requirements of ASTM D6319-00ae3 |
| Dimensions (Width) | Meets requirements of ASTM D6319-00ae3 | Meets requirements of ASTM D6319-00ae3 |
| Dimensions (Thickness - Palm) | Meets requirements of ASTM D6319-00ae3 | Meets requirements of ASTM D6319-00ae3 |
| Dimensions (Thickness - Finger) | Meets requirements of ASTM D6319-00ae3 | Meets requirements of ASTM D6319-00ae3 |
| Tensile Strength (pre-aging min) | 14 MPa (ASTM D6319-00ae3) | 14 MPa |
| Tensile Strength (after-aging min) | 14 MPa (ASTM D6319-00ae3) | 14 MPa |
| Ultimate Elongation (pre-aging min) | 500 % (ASTM D6319-00ae3) | 500 % |
| Ultimate Elongation (after-aging min) | 450 % (ASTM D6319-00ae3) | 450 % |
| Biocompatibility | Meets standards ("Yes", "Limited" duration) | Yes, Limited duration |
| Residual Powder Test | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Physical/Performance Tests (Water Leak, Dimensions, Tensile Strength, Elongation): "Inspection level S-2, AQL 4.0 pinholes at AQL 2.5" is mentioned. This refers to the sampling plan within ASTM D6319-00ae3. It's a standard statistical sampling plan, but the exact number of gloves tested is dependent on the batch size and the specific inspection level and AQL. The document does not provide the explicit sample count.
- Sample Size for Biocompatibility Tests (Dermal Sensitization, Primary Skin Irritation): Not explicitly stated in the document. These tests typically involve a limited number of human subjects or animal models, but specific numbers are not provided.
- Sample Size for Permeation Testing: Not explicitly stated, but ASTM D6978-05 outlines specific requirements for the number of glove samples and the duration of testing with various chemotherapy drugs.
- Data Provenance: The document does not explicitly state the country of origin for the testing data. However, the submitter is Dynarex Corporation (USA). The testing would have been conducted to international standards (ASTM) generally accepted in the US for regulatory submission. The device description mentions the predicate device is from "Shijiazhuang Tillotson Rubber Products Co., Ltd., China," which suggests some manufacturing or relationship there, but the testing itself is submitted by the US company. The tests are retrospective in the sense that they were completed prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of device (patient examination glove) does not typically involve "experts" in the sense of clinicians or radiologists establishing a diagnostic ground truth. The "ground truth" for the performance criteria is defined by the ASTM standards themselves (D6319-00ae3 and D6978-05), which are developed by expert consensus in the field. The results are then objectively measured against the specified thresholds within these standards.
4. Adjudication Method for the Test Set:
Not applicable in the context of this device. Performance is measured against objective, predefined parameters in ASTM standards, not through subjective human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a physical barrier, not an interpretative AI device where human readers interact with AI for diagnostic tasks.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a physical product, not a software algorithm. The "performance" is its physical and chemical properties and barrier integrity.
7. Type of Ground Truth Used:
The ground truth used is based on established industry standards and objective measurements. Specifically:
- Physical properties (dimensions, tensile strength, elongation) are measured objectively against thresholds defined in ASTM D6319-00ae3.
- Barrier integrity (water leak test for pinholes) is measured objectively against AQL levels defined in ASTM D6319-00ae3.
- Biocompatibility (dermal sensitization, irritation) is assessed through standardized tests with predefined pass/fail criteria.
- Chemotherapy drug permeation is determined objectively by measuring drug breakthrough times and rates as per ASTM D6978-05.
8. Sample Size for the Training Set:
Not applicable. This device is a manufactured product, not a machine learning model. There is no concept of a "training set" for the purpose of this 510(k) submission. Manufacturing processes are subject to quality control, which involves ongoing testing, but this isn't a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a machine learning model.
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SEP 1 2 2008
Exhibit # 1
510(K) SUMMARY
Page 1 of 3
THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF THE SAFE MEDICAL DEVICES ACT OF 1990.
| Submitter | Dynarex Corporation10 Glenshaw StreetOrangeburg, NY 10962USAPhone: 845-365-8200Fax: 845-365-8238 |
|---|---|
| Contact Person | Vijay Sachdev |
| Date of Summary | 05-12-2008 |
| Trade Name | Non-sterile Dynarex / Tillotson Nitrile PowderFree Blue Patient Examination Glove, Testedfor use with Chemotherapy Drugs. |
| Common Name | Dynarex / Tillotson Nitrile Powder FreePatient Examination Glove. |
| Classification Name | Dynarex / Tillotson Nitrile Powder FreePatient Examination Glove |
| Predicate Device | Shijiazhuang Tillotson Rubber Products Co.,Ltd., ChinaNon-Sterile Powder-Free Blue NitrileExamination Glove, (K042378). |
| Device Description/ Comparison | Classified by FDA's General and PlasticSurgery Device panel as Class I, 21CFR880.6250, Patient Examination Glove 80 LZA,and meets all requirements of ASTM StandardD6319-00a £3 |
| Intended Use | A patient examination glove is disposabledevice intended for medical purpose that isworn on the examiner's hand or fingers toprevent contamination between patient andexaminer.In addition, these gloves are worn toprotect the wearer against exposure toChemotherapy Drugs. |
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510(K) SUMMARY
Page 2 of 3
Substantial Equivalence Discussion:
A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is substantially equivalent to the predicate devices.
| Characteristic and | Dynarex Corporationn(New Device) | Shijiazhuang TillotsonRubber Products Co., | MEDLINE |
|---|---|---|---|
| parameters | |||
| Product Code | LZA | LZA | LZA |
| Intended Use | A patient examinationglove is disposabledevice intended formedical purpose that isworn on the examiner'shand or fingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves areworn to protect thewearer against exposureto Chemotherapy Drugs. | A patient examinationglove is disposabledevice intended formedical purpose thatis worn on theexaminer's hand orfingers to preventcontaminationbetween patient andexaminer. | Medline Powder-FreeBlue NitrileExamination Gloves(Tested for Use withChemotherapy Drugs)is a disposable deviceintended for medicalpurposes that is wornon the examiner'shand or finger toprevent contaminationbetween patient andexaminer. |
| Width (sizemedium) | 96 mm | 96 mm | 92 mm |
| Overall length | 230 mm | 230 mm | 240 mm |
| Palm thickness | 0.08 mm | 0.08 mm | 0.17 mm |
| Finger thickness | 0.08 mm | 0.08 mm | 0.18 mm |
| Tensile strengthpre aging min | 14 Mpa | 14 Mpa | 21 mpa |
| Tensile strengthafter aging min | 14 Mpa | 14 Mpa | 16 mpa |
| Ultimateelongation preaging min | 500 % | 500 % | 500 % |
| Ultimateelongation afteraging min | 450 % | 450 % | 500 |
| MeetsBiocompatibilitystandards | Yes | Yes | Yes |
| Duration of bio-compatibility | Limited | Limited | Limited |
| Skin irritation test | Passes | Passes | Passes |
| Dermalsensitization | Passes | Passes | Passes |
| Residual powdertest | Passes | Passes | Passes |
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510(K) SUMMARY
Page 3 of 3
Passes
Summary of Testing: Test Results 1. Dermal Sensitization Test
-
- Primary Skin irritation
-
- Permeation testing per ASTM D 6978-05
-
- Water Leak Test
-
- Dimensions (Length, Width, & Thickness) Test
-
- Tensile strength (Before & after aging)
- Ultimate elongation (Before & after aging)
Passes Passes Passes Passes Gloves meets the requirements of ASTM D6319-00ae3. Gloves meets the requirements of ASTM D6319-00ae3
The standards used by Dynarex Corporation to determine substantial equivalence are based on ASTM D 6319-00ae3-2001. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0 pinholes at AQL 2.5
There are special labeling claims "Tested for Chemotherapy". We do not claim our gloves to be hypoallergenic.
Conclusion:
Powder free Blue Nitrile Patient Examination Glove tested with chemotherapy drugs performance was equivalent to any other conventional method evaluation concluded that our device raises no new issues of Safety and effectiveness.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. To the left of the bird is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
SEP 1 2 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Vijay Sachdev Quality Engineer Dynarex Corporation 10 Glenshaw Street Orangeburg, New York 10962
Re: K081569
Trade/Device Name: Non-Sterile Dynarex / Tillotson Nitrile Powder Free Blue Patient Examination Glove, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 18, 2008 Received: August 21, 2008
Dear Mr. Sachdev:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Sachdev
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
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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Attachment 'A'
Indications for Use
510(k) Number (if known):
Device Name: Non-sterile Dynarex / Tillotson Nitrile Powder Free Blue Patient Examination Glove, Tested for use with Chemotherapy Drugs.
Indications For Use:
.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
These gloves are tested for use with Chemotherapy Drugs.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Shula A Murphy
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081569
§ 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.