(100 days)
Not Found
No
The device is a patient examination glove, a simple barrier device. The description and testing focus on physical properties and chemical resistance, with no mention of AI/ML or related concepts.
No
The device is a patient examination glove, which is intended to prevent contamination rather than treat a medical condition.
No
The device is a patient examination glove, which is a barrier to prevent contamination, not a tool for diagnosing medical conditions.
No
The device is a physical patient examination glove, which is a hardware medical device, not software. The description focuses on physical properties and testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or fingers. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: It's classified as a Class I Patient Examination Glove, which is a general medical device, not specifically an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The testing mentioned (dermal sensitization, skin irritation, permeation, water leak, dimensions, tensile strength, elongation) are all related to the physical properties and safety of the glove as a barrier device, not its ability to perform a diagnostic test.
N/A
Intended Use / 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.
In addition, these gloves are worn to protect the wearer against exposure to Chemotherapy Drugs.
These gloves are tested for use with Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
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 £3
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical purpose
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Dermal Sensitization Test: Passes
- Primary Skin irritation: Passes
- Permeation testing per ASTM D 6978-05: Passes
- Water Leak Test: Passes
- Dimensions (Length, Width, & Thickness) Test: Gloves meets the requirements of ASTM D6319-00ae3.
- Tensile strength (Before & after aging): Gloves meets the requirements of ASTM D6319-00ae3
- Ultimate elongation (Before & after aging): 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Corporation
10 Glenshaw Street
Orangeburg, NY 10962
USA
Phone: 845-365-8200
Fax: 845-365-8238 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Vijay Sachdev |
| Date of Summary | 05-12-2008 |
| Trade Name | Non-sterile Dynarex / Tillotson Nitrile Powder
Free Blue Patient Examination Glove, Tested
for use with Chemotherapy Drugs. |
| Common Name | Dynarex / Tillotson Nitrile Powder Free
Patient Examination Glove. |
| Classification Name | Dynarex / Tillotson Nitrile Powder Free
Patient Examination Glove |
| Predicate Device | Shijiazhuang Tillotson Rubber Products Co.,
Ltd., China
Non-Sterile Powder-Free Blue Nitrile
Examination Glove, (K042378). |
| Device Description/ Comparison | 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 £3 |
| Intended 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.
In addition, these gloves are worn to
protect the wearer against exposure to
Chemotherapy Drugs. |
1
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 Tillotson
Rubber Products Co., | MEDLINE |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| parameters | | | |
| Product Code | LZA | LZA | LZA |
| Intended 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. In
addition, these gloves are
worn to protect the
wearer against exposure
to Chemotherapy Drugs. | 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. | Medline Powder-Free
Blue Nitrile
Examination Gloves
(Tested for Use with
Chemotherapy Drugs)
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. |
| Width (size
medium) | 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 strength
pre aging min | 14 Mpa | 14 Mpa | 21 mpa |
| Tensile strength
after aging min | 14 Mpa | 14 Mpa | 16 mpa |
| Ultimate
elongation pre
aging min | 500 % | 500 % | 500 % |
| Ultimate
elongation after
aging min | 450 % | 450 % | 500 |
| Meets
Biocompatibility
standards | Yes | Yes | Yes |
| Duration of bio-
compatibility | Limited | Limited | Limited |
| Skin irritation test | Passes | Passes | Passes |
| Dermal
sensitization | Passes | Passes | Passes |
| Residual powder
test | Passes | Passes | Passes |
2
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.
3
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.
4
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
5
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