(45 days)
Not Found
80LYY
No
The device description and performance studies focus on the physical properties and biocompatibility of a standard examination glove, with no mention of AI or ML.
No
The device is described as an examination glove intended to prevent contamination between healthcare personnel and patients, not to treat or alleviate a medical condition.
No
Explanation: The device is an examination glove, which is used to prevent contamination. Its function is not to diagnose any condition or disease.
No
The device is a physical glove made of natural rubber latex, not software. The description focuses on material properties and physical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the material (natural rubber latex), form (powdered glove), and standards it meets (ASTM D-3578-05, 21 CFR 880.6250). This aligns with a medical device used for physical protection.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on physical properties and biocompatibility, not analytical performance related to biological specimens.
- Predicate Device: The predicate device is a "Class 1 Patient Examination glove bearing the product code 80LYY ( 21 CFR 880.6250 )." This product code and classification are for general medical devices, not IVDs.
In summary, the device is a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Powdered Natural Rubber Latex Examination Gloves are intended for single use for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patients.
Product codes
80LYY, LYY
Device Description
Powdered Natural Rubber Latex Examination Glove is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-05, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powdered.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care and similar personnel
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)
Non-Clinical Tests:
Testing performed per ASTM D 3578-05, Standard Specification for Rubber Examination Gloves and 21 CFR 800.20. Gloves meet all the current ASTM D 3578-05. Primary skin irritation testing in the rabbit and delayed dermal contact sensitization study in the guinea pigs indicate no irritation or sensitization.
Conclusions: Non-Clinical laboratory and animal test data indicate that the powdered product meets all performance and biocompatibility requirements.
Clinical Tests: No new clinical tests were conducted under this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Attachment 17
K070821
510(k) SUMMARY
MAY 1 0 2007
POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES
| Submitter's Name | MEDTEXX MANUFACTURING SDN. BHD. |
|---|---|
| Submitter's Address | PT 4004, Kamunting Industrial Estate |
| 34600 Taiping, Perak, | |
| Malaysia | |
| Submitter's Phone Number | 605-891 1111 / 605-891 5555 |
| Submitter's Fax Number | 605-891 1088 |
| Name of Contact Person | Ooi Loon Seng |
| Date of Preparation | |
| Name of Device | |
| Trade Name | : POWDERED NATURAL RUBBER LATEX |
| EXAMINATION GLOVES | |
| Common Name | : Latex Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Legally Marketed Device to which Equivalency is | |
| Being Claimed | Powdered Natural Rubber Latex Examination |
| Gloves as described in this 510 K Notification is | |
| substantially equivalent to the current Class 1 | |
| Patient Examination glove bearing the product | |
| code 80LYY ( 21 CFR 880.6250 ). It meets all the | |
| current specifications listed under the ASTM | |
| Specification D 3578-05, Standard Specification | |
| for Rubber Examination Gloves. | |
| Description of the Device | Powdered Natural Rubber Latex Examination |
| Glove is substantially equivalent to the Class 1 | |
| patient examination glove bearing the product | |
| code 80LYY ( 21 CFR 880.6250 ). It meets all the |
1
| | current specifications listed under the ASTM
Specification D-3578-05, Standard Specification
for Rubber Examination Gloves. They are made
from natural rubber latex. They are natural white
in color and are powdered. |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of the Device | Powdered Natural Rubber Latex Examination
Gloves are intended for single use for medical
purposes that is worn on the hand of health care
and similar personnel to prevent contamination
between the health care personnel and the
patients. |
| Summary of Technological Characteristic
Compared to the Predicate Device | There is no different technological characteristic.
Gloves are made from natural rubber latex
compound and the initial products are powdered
natural rubber latex examination gloves. |
| Brief Description of Non-Clinical Tests | Testing performed per ASTM
D 3578-05,
Standard Specification for Rubber Examination
Gloves and 21 CFR 800.20. Gloves meet all the
current ASTM D 3578-05.
Primary skin irritation testing in the rabbit and
delayed dermal contact sensitization study in the
guinea pigs indicate no irritation or sensitization. |
| Brief description of Clinical Tests | No new clinical tests were conducted under this
510(k). |
| Conclusions Drawn from the Non-Clinical and
Clinical Tests | Non-Clinical laboratory and animal test data
indicate that the powdered product meets all
performance and biocompatibility requirements. |
| Other Information Deemed Necessary by FDA | Not Applicable |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring four human figures in profile, arranged in a stacked formation. The figures are connected and appear to be facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2007
Mdm. Ooi Loon Seng Regulatory Affairs Manager Medtexx Manufacturing Sdn. Bhd. PT 4004 Kamunting Industrial Estate, Taiping Kamunting Perak, 34600 MALAYSIA
Re: K070821
Trade/Device Name: Powdered Natural Rubber Latex Examination Gloves (Protein Label Claim) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: March 23, 2007 Received: March 26, 2006
Dear Mdm. Seng:
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.
3
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 Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Suver Kune
Chin Lin, Ph.D.
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
4
INDICATIONS FOR USE
Applicant
MEDTEXX MANUFACTURING SDN. BHD. PT 4004, Kamunting Industrial Estate, 34600 Kamunting , Perak, Malaysia.
510(k) Number (if known)
070821
Device Name
POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
Indications For Use
Powdered Natural Rubber Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE )
Prescription Use Per 21 CFR 801.109 OR Over-The-Counter
Shule V. Murphy Ko
Anestiiesiology, General Hospal,
Jon Control, Demal Devices
ck) Number: K/0 821