(142 days)
A disposable medical glove to be worn on the hand of the healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Non-sterile , Powder-free Blue Nitrile Examination Gloves , Tested for use with Chemotherapy Drugs.
The provided documents describe the performance of "Non-sterile, Powder-free Blue Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs" (K101822) against various acceptance criteria relevant to medical examination gloves and specifically for their resistance to chemotherapy drugs.
Here’s a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are largely based on established ASTM (American Society for Testing and Materials) standards and a comparison to a legally marketed predicate device (K082957). The key performance indicator for chemotherapy drug resistance is the "Breakthrough Detection Time" as per ASTM D6978-05.
Acceptance Criteria and Reported Device Performance for K101822
| Characteristic and Parameter | Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| General Glove Characteristics | |||
| Device Class | Class I (as per predicate) | Class I | Yes |
| Product Code | LZA (as per predicate) | LZA | Yes |
| Glove Color | Blue (as per predicate) | Blue | Yes |
| Dimensions | Meets ASTM D6319-00a-05 | Meets ASTM D6319-00a-05 | Yes |
| Physical Properties | Meets ASTM D6319-00a-05 | Meets ASTM D6319-00a-05 | Yes |
| Freedom From Pinholes | Meets ASTM D6319-00a-05 (and/or ISO 2859-1, ASTM D5151-06) | Meets ASTM D6319-00a-05 | Yes |
| Powder-free | Meets ASTM D6124-06 | Meets ASTM D6124-06 | Yes |
| Biocompatibility | |||
| Primary Skin Irritation | Passes Primary Skin Irritation in Rabbits (as per predicate) | Passes Primary Skin Irritation in Rabbits | Yes |
| Sensitization | Passes Guinea Pig Maximization (similar to predicate's Guinea Pig Sensitization) | Passes Guinea Pig Maximization | Yes |
| Chemotherapy Drugs Permeation (ASTM D6978-05) | |||
| Cisplatin | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Cyclophosphamide (Cytoxan) | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Doxorubicin Hydrochloride | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Etoposide (Toposar) | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Flurouracil | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Paclitaxel (Taxol) | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Vincristine Sulfate | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Dacarbazine (DTIC) | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Methotrexate | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Carmustine (BCNU) | Not specified as a pass/fail threshold, but noted as having extremely low permeation time in the predicate | 0.49 minutes | No (Note: Not approved for use with this drug) |
| Thiotepa | Not specified as a pass/fail threshold, but noted as having extremely low permeation time in the predicate | 2.61 minutes | No (Note: Not approved for use with this drug) |
| Labeling | Meets FDA requirement | Meets FDA requirement | Yes |
Summary of Study Proving Acceptance:
The device K101822 was shown to meet its acceptance criteria through various tests described in the "Substantial Equivalence Discussion" (Document 2, page 2 of 2) and the "CONCLUSION" (Document 4, page 1 of 1). The primary study for chemotherapy drug resistance was conducted according to ASTM D6978-05. For other characteristics like dimensions, physical properties, freedom from pinholes, and powder-free status, the device was tested against and found to meet ASTM D6319-00a-05, ISO 2859-1 (for water leak test), ASTM D5151-06 (for detection of holes), and ASTM D6124-06 respectively. Biocompatibility tests included Primary Skin Irritation in Rabbits and Guinea Pig Maximization tests.
The device's performance was directly compared to a legally marketed predicate device, Siam Sempermed Corp. Ltd.'s Non-sterile, Powder-free Nitrile Examination Glove (K082957), showing substantial equivalence in all tested parameters, except for highlighting the short permeation times for Carmustine (BCNU) and Thiotepa, for which the gloves are explicitly not approved.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The specific sample sizes for each test (e.g., number of gloves tested for chemotherapy permeation, number of rabbits/guinea pigs for biocompatibility, or specific counts for physical properties) are not explicitly stated in the provided documents. The documents only state that the device "Meets ASTM D6319-00a-05," "Meets ASTM D6124-06", etc., which implies that the testing was performed according to the methodologies and sample size requirements specified in those respective ASTM/ISO standards.
- Data Provenance: The data is presented as part of a 510(k) Premarket Notification submission to the FDA by SGMP Company Limited, located in Thailand (Document 0, page 1 of 2). This indicates the testing was conducted by or on behalf of the manufacturer, and generally, such data would be generated in a controlled laboratory environment. The documents do not specify the country of origin of the specific lab that conducted these tests, but the manufacturer is based in Thailand. The studies were retrospective in the sense that they were conducted to characterize the finished medical device for regulatory submission, rather than as part of a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device submission. The "ground truth" for the performance of these examination gloves is established through standardized laboratory tests (e.g., ASTM standards) measuring physical and chemical properties, not through expert human interpretation or clinical ground truth. Therefore, there are no "experts" in the sense of medical professionals establishing ground truth for diagnostic accuracy, nor are their qualifications relevant here.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human judgment (e.g., for image interpretation) to resolve disagreements among experts. The performance of these gloves is determined by objective, quantitative laboratory measurements according to published standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. An MRMC study is relevant for diagnostic devices (e.g., AI algorithms for image interpretation) where human readers evaluate cases with and without AI assistance. This submission describes an examination glove, which is a physical barrier device, and does not involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. This describes a physical medical device (examination gloves), not an algorithm or AI system.
7. The type of ground truth used
The ground truth used for performance validation is based on objective, quantitative measurements obtained through standardized laboratory testing protocols, primarily from ASTM standards (D6319-00a-05, D6124-06, D6978-05) and ISO 2859-1. For biocompatibility, the ground truth is established by the observed biological responses in animal models (rabbits and guinea pigs) according to standardized tests for skin irritation and sensitization. The device's performance is then compared against the requirements specified in these standards and against the performance of a legally marketed predicate device.
8. The sample size for the training set
This question is not applicable. This is a physical medical device, not an AI model or algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this type of device.
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APPENDIX M
( k) SUMMARY 210
( As Required by 21 section 807.92 (c) )
- Submitted For : SGMP Company Limited 181 Moo 6, Tambol Kampaengphet , Rattaphum , Songkhla 90180 Thailand, 2. Submitted By : Tucker & Associates Official Correspondent for SGMP Company Limited Janna P. Tucker , President - CEO 198 , Avenue de la D'emerald , Sparks, NV 89434-9550 Phone No : 775-342-2612 Fax No : 775-342-2613 Email : Tuckerjan@aol.com r
3. Device Trade or Proprietary Name :
Non-sterile , Powder-free Blue Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs.
-
- Device Common Name : Examination Gloves
5. Device Classification Name :
Patient Examination Gloves ( per 21CFR 880.6250)
6. Device Description :
Non-sterile , Powder-free Blue Nitrile Examination Gloves , Tested for use with Chemotherapy Drugs.
7. Intended Use of Device :
A disposable medical glove to be worn on the hand of the healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
ATCH 2
APPENDIX M revised 10-12-10, James Packer
Now shows equivalence to K082957.
NOV 1 9 2010
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K101822
The Non-sterile Powder Free Blue Nitrile Examination Gloves Tested for uses with The Non-sterile Powder Free Blue device intended for medical purposes that is world on the Chemotherapy Drugs , is a disposable device intended to models paper
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
In Minutes of the March and with these gloves Chemotherapy Drug i cinicallon (Broadiness). The following chemical
| Test Chemotherapy Drug | Average Breakthrough Detection Time (Minutes) |
|---|---|
| *Carmustine (BCNU) | 0.49 minutes |
| Cisplatin | >240 minutes |
| Cyclophosphamide (Cytoxan) | >240 minutes |
| Doxorubicin Hydrochloride | >240 minutes |
| Etoposide (Toposar) | >240 minutes |
| Flurouracil | >240 minutes |
| Paclitaxel (Taxol) | >240 minutes |
| *Thiotepa | 2.61 minutes |
| Vincristine Sulfate | >240 minutes |
| Dacarbazine (DTIC) | >240 minutes |
| Methotrexate | >240 minutes |
*Please note that Carmustine (BCNU) and Thiotepa have extremely low Prease Bott that of 0.49 and 2.61 minute only.
ﺮ
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KID/822
(1) = 1.
・
· 8. Substantial Equivalence Discussion :
.
... ..
ﻨﻲ
| Characteristic andParameter | SGMP Company LimitedNon-sterile , Powder-free Blue NitrileExamination Gloves.Tested for use with ChemotherapyDrugs | Siam Sempermed Corp.Ltd.Non-sterile , Powder-free NitrileExamination Glove , Blue withPolymer Coating, Tested for usewith Chemotherapy Drugs510 K # K082957 | SubstantialEquivalence(SE) |
|---|---|---|---|
| Devise Class | 1 | 1 | SE |
| Product Code | LZA | LZA | SE |
| Glove Color | Blue | Blue | SE |
| Dimensions | Meets ASTM D6319-00a-05 | Meets ASTM D6319-00a-05 | SE |
| PhysicalProperties | Meets ASTM D6319-00a-05 | Meets ASTM D6319-00a-05 | SE |
| Freedom FromPinholes | Meets ASTM D6319-00a-05 | Meets ASTM D6319-00a-05 | SE |
| Powder-free | Meets ASTM D6124-06 | Meets ASTM D6124-06 | SE |
| BiocompatibilityTest | Passes Primary Skin Irritationin Rabbits | Passes Primary Skin Irritationin Rabbits | SE |
| Passes Guinea PigMaximization | Passes Guinea PigSensitization | SE | |
| ChemotherapyDrugs Tests | Meets ASTM D6978-05Cisplatin > 240 mins | Meets ASTM D6978-05Cisplatin > 240 mins | SE |
| Cyclophosphamide > 240 minsDoxorubicin Hydrochloride | Cyclophosphamide > 240 minsDoxorubicin Hydrochloride | ||
| > 240 minsEtoposide > 240 mins | > 240 minsEtoposide > 240 mins | ||
| Flurouracil > 240 minsPaclitaxel > 240 mins | Flurouracil > 240 minsPaclitaxel > 240 mins | ||
| Vencristine Sulfate > 240 minsDacarbazine > 240 mins | Vencristine Sulfate > 240 minsDacarbazine > 240 mins | ||
| Methotrexate > 240 mins | Methotrexate > 240 mins |
.
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:
.
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CONCLUSION:
The data presented indicates the Powder-Free, Blue Nitrile Examination Gloves, Tested I the una presence managers wabeling Claim, (Non-Sterile), K.101822 is equivalent 101 OSC With Channellapy Doles-free Nitrile Examination Gloves, Blue with Polymer Coating, Tested for use with Chemotherapy Drugs.
It should be noted that testing for use with two chemotherapy drugs had extremely It should be loced use total use as follows: CARMUSTINE (BCNU) @ 0.49 minutes, and iow permeation unles. Therefore, these gloves are not approved for use when using those chemo drugs.
These gloves do meet the following recognized standards unless otherwise noted:
ASTM D6319-00a00A(2005), Standard Specification for Nitrile Gloves
ISO 2859-1, Standard for Water Leak Test and/or ASTM D5151-06, Test Method for Detection of Holes in Medical Gloves
ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves.
Biocompatibility Testing on White Rabbits and Guinea Pigs,
Labeling meets FDA requirement
Substantially equivalent to Siam Sempermed Corp. Ltd. K082957
ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
{5}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of a circle. The symbol on the right features a stylized human figure with three arms, representing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SGMP Company, Limited C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'Emerald Sparks. Nevada 89434
NOV 1 9 2010
Re: K101822
Trade/Device Name: Non-Sterile, Powder Free Blue Nitrile Examination Gloves Tested for use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA/LZC Dated: October 22, 2010 Received: October 21, 2010
Dear Ms. Tucker:
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.
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Anthony D. 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
Enclosure
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INDICATION FOR USE STATEMENT
-00.
| Applicant : SGMP Company Limited | |
|---|---|
| 510K NUMBER: K10 1822 | |
| Device Name : Non-Sterile, Powder Free Blue Nitrile Examination Gloves , Tested for use withChemotherapy Drugs. | |
| Indication For Use : | |
| The Non-sterile Powder Free Blue Nitrile Examination Gloves Tested for use withChemotherapy Drugs , is a disposable device intended for medical purposes that is worn on theexaminer's hand or finger to prevent contamination between patient and examiner. | |
| Chemotherapy Drug Permeation (Breakthrough Detection Time) in MinutesThe following chemical have been tested with these gloves. | |
| Test Chemotherapy Drug | Average BreakthroughDetection Time (Minutes) |
| *Carmustine (BCNU) | 0.49 minutes |
| Cisplatin | >240 minutes |
| Cyclophosphamide (Cytoxan) | >240 minutes |
| Doxorubicin Hydrochloride | >240 minutes |
| Etoposide (Toposar) | >240 minutes |
| Flurouracil | >240 minutes |
| Paclitaxel (Taxol) | >240 minutes |
| *Thiotepa | 2.61 minutes |
| Vincristine Sulfate | >240 minutes |
| Dacarbazine (DTIC) | >240 minutes |
*Please note that Carmustine (BCNU) and Thiotepa have extremely low permeation times of 0.49 and 2.61 minute only.
Prescription Use 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§ 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.