(100 days)
K/DEN: Not Found
No
The device is a medical examination glove, and the description focuses on its material properties and barrier function. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The input describes an examination glove, which provides a barrier against contaminants, but is not used for treating or diagnosing medical conditions.
No
The device is described as an examination glove intended to provide a barrier against infectious materials, not to diagnose any condition.
No
The device is a physical examination glove made of nitrile rubber, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for "medical purposes to provide a barrier against potentially infectious materials and other contaminants." This describes a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description focuses on the physical properties of the nitrile rubber and its ability to form a barrier. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a patient's health status.
The device is a medical examination glove, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
This is a disposable device, intended for medical purpose, that is worn on the examiner's hand to prevent contamination between patient and examiner. Powder-free examination gloves are suitable in situations where powder is not desirable.
This green powder-free nitrile examination glove is a disposable device made of nitrile rubber that may bear trace amount of powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants (21 CFR 880.6250).
Product codes
80LZA, LZA
Device Description
-
a. Basis of scientific concepts for the device:
Nitrile rubber is impermeable to water and body fluids under normal manipulations of the hand to enable it to conform to conditions of double manipulations for medical procedures. -
b. Physical and performance characteristics such as design, material, and physical properties:
Nitrile rubber is known to form a superior barrier to bloodborne pathogens and conform to a specified in ASTM D6319-00ae3 nitrile physical properties for medical examination procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non-clinical tests:
- Freedom From Holes: ASTM D6319-00ae3, ASTM D5151-99, FDA 21 CFR 800.20 - Meets (Device Performance This Submission and Predicate K030207)
- Powder-Free Residual: ASTM D6124-01 - Meets, Less than 2 mg/glove (Device Performance This Submission and Predicate K030207)
- Physical Properties: ASTM D6319-00ae3 - Meets (Device Performance This Submission and Predicate K030207)
- Dimensions: ASTM D6319-00ae3 - Meets (Device Performance This Submission and Predicate K030207)
Animal Clinical Tests:
- Primary Skin Irritation: ISO 10993 Biological Evaluation of Medical Devices, Part 10 - Passes
- Dermal Sensitization: Guinea Pig Sensitization Buehler Method - Passes
Conclusions: The data summaries indicate that the proposed device meets the established performance standards for non-sterile powder-free patient nitrile examination gloves, and that the proposed device is substantially equivalent to predicate K030207.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and letters. The sequence is K041276. The characters are written in a dark ink on a white background.
510(K) SUBMISSION FOR GREEN POWDER-FREE NITRILE EXAMINATION GLOVES
ΑΤΤΑCHΜΕΝΤ Χ
510(K) SUMMARY
l. INFORMATION
| SUMMITTER'S Name: | SHANGHAI MOTEX HEALTHCARE CO., LTD. |
|---|---|
| Address: | Shanghai Motex Heathcare Co., Ltd. No. 359, Jiasong Zhong Road Huaxin, Qingpu Shanghai, China 201708 |
| Contact Person: | Tony T. K. Cheng |
| Phone: | 86-21-59799888 |
| Fax: | 86-21-59799728 |
| Date of Preparation: | July 14, 2004 |
NAME OF DEVICE
| Trade or Proprietary Name: | 1) Prodermic Green Powder-Free Nitrile Examination Glove 2) Multiple or Customer's Trade Names |
|---|---|
| Common or Usual Name: | Non-Sterile Nitrile Power-Free Patient Examination Glove |
| Classification Name: | Patient Examination Glove, Powder-Free (per 21 CFR 880.6250) |
IDENTIFICATION OF THE LEGALLY MARKETED DEVICE
Class I Patient Examination Glove, 80LZA, powder-free, that meets all Olass Pration: Examination 93319-00ae3 and FDA 21 CFR 800.20.
PREDICATE DEVICE
Pro-Blue Powder-Free Medical Examination Glove, K030207
PAGE 24 OF 27
1
DESCRIPTION OF DEVICE 5
-
a. Basis of scientific concepts for the device:
Nitrile rubber is impermeable to water and body fluids under normal Nithle rubber is impormouslations of the enable it to conform to conditions of doible manipulations for medical procedures. -
b. Physical and performance characteristics such as design, material, and physical properties:
Nitrile rubber is known to form a superior barrier to bloodborne Nithle rabber is known to form a rom a specified in ASTM D6319-00ae3 nitrile pathogono and become physical properties for medical examination procedures.
INTENDED USE OF THE DEVICE 6.
This is a disposable device, intended for medical purpose, that is 1115 15 a the examiner's hand to prevent contamination between worn on the oxaminer o hander-free examination gloves are suitable in situations where powder is not desirable.
EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE
The proposed device is substantially equivalent to the predicate device K030207 except for the following:
- a) Color additive is different: green for the proposed device and blue for the predicate device.
- b) The accelerators/sulfur mixture used in the predicate device has been replaced by a synthetic polymer with reactive functional groups to achieve balanced physical properties.
- SUMMARY OF PERFORMANCE DATA: 11.
PAGE 25 OF 27
2
510(K) SUBMISSION FOR GREEN POWDER-FREE NITRILE EXAMINATION GLOVES
1. DISCUSSION OF NON-CLINICAL TESTS
| CHARACTER
-ISTICS | STANDARDS | DEVICE
PERFORMANCE
THIS
SUBMISSION | DEVICE
PERFORMANCE
PREDICATE
K030207 |
|-------------------------|--------------------------------------------------------|---------------------------------------------|-----------------------------------------------|
| Freedom
From Holes | ASTM D6319-00ae3
ASTM D5151-99
FDA 21 CFR 800.20 | Meets | Meets |
| Powder-Free
Residual | ASTM D6124-01 | Meets, Less than
2 mg/glove | Meets, Less than
2 mg/glove |
| Physical
Properties | ASTM D6319-00ae3 | Meets | Meets |
| Dimensions | ASTM D6319-00ae3 | Meets | Meets |
2. DISCUSSION OF ANIMAL CLINICAL TESTS
| CHARATERISTICS | STANDARDS/METHODS | DEVICE PERFORMANCE |
|---|---|---|
| Primary Skin | ||
| Irritation | ISO 10993 | |
| Biological Evaluation of | ||
| Medical Devices, Part 10 | Passes | |
| Dermal Sensitization | Guinea Pig Sensitization | |
| Buehler Method | Passes |
3. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY AND EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT
The data summaries indicate that the proposed device meets the established performance standards for non-sterile powder-free patient nitrile examination gloves, and that the proposed device is substantially equivalent to predicate K030207
Pursuant to 21 C.F. R. 807.87(j), 1, Tony T.K. Cheng certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as Managing Director for the Shanghai Motex Healthcare Co., Ltd.,
PAGE 26 OF 27
3
510(K) SUBMISSION FOR GREEN POWDER-FREE NITRILE EXAMINATION GLOVES
and in the reliance thereupon, the data and information submitted and in the reliance thereupon, the usual circuthful and accurate and that no
in this Premarket notification are truthful and accurate of this in this Prematket nothloation are trastral equivalence of this facts material to a review of the submission.
T. Horibe
7/14/2004
Date
Tony T.K. Cheng, Managing Director
Date
PAGE 27 OF 27
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2004
Shanghai Motex Healthcare Company Limited C/O Dr. Wunan Huang At Tech, Incorporated 150J West Phillips Road Greer, South Carolina 29650
Re: K041276
Trade/Device Name: Green Nitrile Powder-Free Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 30, 2004 Received: August 2, 2004
Dear Dr. Huang:
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.
5
Page 2 - Dr. Huang
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 (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.
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 Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
6
Indications for Use
510(k) Number (if known): K041276
Device Name:__Green Nitrile Powder-Free Examination Gloves
Indications For Use: This green powder-free nitrile examination glove is a disposable device made of nitrile rubber that may bear trace amount of powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants (21 CFR 880.6250).
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)
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital. | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K041276 |