(259 days)
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML.
No
The device, examination gloves, is intended to prevent contamination and is not used to treat or cure a disease or condition.
No
The device is an examination glove, worn on the hand to prevent contamination, which is a protective and barrier function, not a diagnostic one.
No
The device is a physical examination glove made of natural rubber latex, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the material (natural rubber latex), physical characteristics (powder free, color), and compliance with standards for examination gloves. There is no mention of analyzing samples from the body or providing diagnostic information.
- 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 or measuring substances in the body
- Providing information for diagnosis, monitoring, or treatment decisions
- Using reagents or assays
The device is a Class I medical device intended for barrier protection during medical procedures.
N/A
Intended Use / Indications for Use
MPXX™ Powder Free Natural Rubber Latex Examination Gloves are intended for single use for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Product codes
LYY, 80LYY
Device Description
MPXX™™ Powder Free Natural Rubber Latex Examination Gloves are 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 powder free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
on the hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare 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 laboratory and animal based test data indicate that the powder free product meets all performance and biocompatibility requirements.
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
K110250
OCT 1 4 2011
MPXX™ POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
| Submitter's Name | TOTAL GLOVE COMPANY SDN. BHD. |
|---|---|
| Submitter's Address | Lot 2584, Jalan Perusahaan 3, |
| Kamunting Industrial Estate | |
| 34600 Taiping, Perak, | |
| Malaysia | |
| Submitter's Phone Number | 605-8295 512 |
| Submitter's Fax Number | 605-8915 500 |
| Name of Contact Person | Ooi Loon Seng |
| Date of Preparation | 06 October 2011 |
| Name of Device | |
| Trade Name | : MPXX™ POWDER FREE NATURAL RUBBER |
| LATEX EXAMINATION GLOVES | |
| Common Name | : Latex Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Legally Marketed Device to which Equivalency is | |
| Being Claimed | MPXX™ Powder Free Natural Rubber Latex |
| Examination Gloves as described in this 510 K | |
| Notification is substantially equivalent to | |
| K981767, Qtexx Powder-Free Latex Examination | |
| Gloves with 50 Micrograms or Less of Total | |
| Water Extractable Protein Per Gram which is 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 | MPXX™™ Powder Free Natural Rubber Latex |
| Examination Gloves are 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 powder free. | |
| Intended Use of the Device | MPXX™™ Powder Free Natural Rubber Latex |
| Examination Gloves are intended for single use | |
| for medical purposes that is worn on the hand of | |
| healthcare and similar personnel to prevent | |
| contamination between healthcare personnel and | |
| the patient. | |
| 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 low | |
| powdered natural rubber latex gloves. These | |
| gloves are using the existing technology, i.e. | |
| multiple washing and rinsing processes. | |
| Brief Description of Non-Clinical Tests | Testing were 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 requirements. | |
| Primary skin irritation testing in the rabbit and | |
| delayed contact sensitization testing in the | |
| guinea pig indicate no irritation or sensitization. | |
| Final product has been tested negative for the | |
| presence of starch using the USP iodine test. | |
| 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 based test |
| data indicate that the powder free product meets | |
| all performance and biocompatibility | |
| requirements. | |
| Other Information Deemed Necessary by FDA | Not Applicable. |
1
:
·
/
2
.
| Characteristics
and Parameters | Subject Device
MPXX™ Powder Free
Natural Rubber Latex
Examination Gloves | Predicate Device
Qtexx Powder-Free
Latex Examination
Gloves with 50
Micrograms or Less of
Total Water
Extractable Protein Per
Gram (K981767) | Substantial
Equivalence
(SE) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | 80LYY | 80LYY | |
| Intended Use | MPXX™ Powder Free
Natural Rubber Latex
Examination Gloves is a
single use device
intended for medical
purposes that is worn on
the hand of healthcare
and similar personnel to
prevent contamination
between healthcare
personnel and the
patient. | Qtexx Powder-Free
Latex Examination
Gloves with 50
Micrograms or Less of
Total Water Extractable
Protein Per Gram is a
single use device
intended 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
patient. | Yes,
Substantial
Equivalence |
| Glove Thickness
and Length | Meets ASTM D 3578-05:
-Palm Thickness of ≥
0.08mm
-Finger Thickness ≥
0.08mm
-Length ≥ 240mm | Meets ASTM D 3578-95:
-Palm Thickness of ≥
0.08mm
-Finger Thickness ≥
0.08mm
-Length ≥ 230mm | Yes,
Substantial
Equivalence |
| Tensile Strength | Meets ASTM D 3578-05:
- Tensile Strength ≥
18MPa (≥ 18MPa per
Standard ) - Elongation ≥ 650% | Meets ASTM D 3578-95:
- Tensile Strength ≥
14MPa (≥ 14MPa per
Standard ) - Elongation ≥ 700% | Yes,
Substantial
Equivalence |
| Freedom from
Holes | Meets Requirements per
21CFR800.20:
Gloves Free of Holes at
quality level of AQL 1.5
(AQL 2.5 required per
standard) | Meets Requirements per
21CFR800.20:
Gloves Free of Holes at
quality level of AQL 1.5
(AQL 2.5 required per
standard) | Yes, Identical |
| Materials | Natural Rubber Latex | Natural Rubber Latex | Yes,
Substantial
Equivalence |
| Color | Natural Color | Natural Color | Yes, Identical |
| Biocompatibility | Passes: - Primary Skin Irritation
- Dermal Sensitization | Passes:
- Primary Skin Irritation
- Dermal Sensitization | Yes, Identical |
| Powder Free | Meets Applicable
Definition for Powder
Free; ≤ 2 mg per glove | Meets Applicable
Definition for Powder
Free: ≤ 2 mg per
glove | Yes, Identical |
| Protein Content | Meets Applicable
Definition for Protein
Content; ≤ max 50
(ug/dm²) | Meets Applicable
Definition for Protein
Content; ≤ max 50
(ug/dm²) | Yes, Identical |
| Sterility | Not applicable: Non-
sterile | Not applicable: Non-
sterile | Yes, Identical |
Substantial Equivalence Comparison Table
. 1
,
3
MPXX™ Powder Free Natural Rubber Latex Examination Gloves
:
:
.
.
:
100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -
. .
.
.
. .
.
.
.
4
Image /page/4/Picture/1 description: The image shows a circular seal or emblem. The seal features a stylized graphic of three curved lines, resembling a bird in flight or a flowing design. Encircling the graphic is text, which appears to be part of the seal's official designation, possibly related to a government agency or organization.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 4 2011
Total Gloves. SDN BHD C/O Ms. Ooi Loon Seng Regulatory Affairs Manager Lot 2584, Jalan Perusahaan 3. Kamunting Industrial Estate Taipang City, Perak Province MALAYSIA 34600
Re: K110250
Trade/Device Name: MPXX" Powder-Free Natural Rubber Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LY Y Dated: September 12, 2011 Received: September 16, 2011
Dear Ms. 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. 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.
5
Page 2 - Ms. Seng
Enclosure
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Antimony D. Matson
Anthony B. 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
6
MPXX IM Powder Free Natural Rubber Latex Examination Gloves
Attachment 2
INDICATIONS FOR USE K110250
Applicant TOTAL GLOVE COMPANY SDN. BHD. Lot 2584, Jalan Perusahaan 3, Kamunting Industrial Estate, 34600 Kamunting , Perak, Malaysia.
510(k) Number K110250 -(if known)
Device Name
MPXX™ Powder Free Natural Rubber Latex Examination Gloves
Indications For Use
MPXX™ Powder Free Natural Rubber Latex Examination Gloves are intended for single use for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Eghert R.C.C. Laimins W.M.S
(Division Sign-Off) Concurrence of CDRH Office of Device Evaluation (ODE ) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110250
Prescription Use Per 21 CFR 801.109
OR Over-The-Counter