Medically Reviewed & Authored by: George King
R&D Manager & Emergency Preparedness Specialist at Fitiger Life LLC
Updated on March 17, 2026
What matters most
In a choking emergency, parents usually focus entirely on speed. As the engineering and product safety team at Fitiger, we have to answer a second, equally critical question: what do we know about the material pressed against a child’s face during that response?
We do not rely on vague “safe material” language. We evaluate FoldPumpVac’s patient-contact components within a biological evaluation framework aligned with ISO 10993 and GB/T 16886. Our goal is to verify, through recognized laboratory methods, whether the mask material shows cytotoxicity potential, irritation potential, or sensitization potential. In our third-party laboratory testing, the FoldPumpVac mask material met the stated acceptance criteria across the three evaluated endpoints. These results support the conclusion that the tested material did not show cytotoxic potential, met the irritation acceptance criterion, and did not induce sensitization under the reported laboratory conditions.
Why this testing matters for a rescue device
You cannot judge a rescue device solely by suction performance. You also have to evaluate how its patient-contact materials behave.
Biological evaluation under ISO 10993 is a structured risk-management process. FDA’s biocompatibility guidance uses ISO 10993-1 as a risk-based framework to support biological evaluation for medical device submissions. The specific endpoints depend on the nature of body contact, the duration of contact, and the overall material risk profile. For a patient-contact mask, three baseline questions matter: do material extracts reduce cell viability, do they trigger localized irritation, and do they show sensitization potential?
Do material extracts reduce cell viability?
Do they trigger localized irritation?
Do they show sensitization potential?
Here is how our FoldPumpVac testing answered those questions.
1) Cytotoxicity: do the extracts harm cells?
Cytotoxicity testing is a baseline screen. It evaluates whether chemical extracts from a material reduce cell viability under defined in vitro conditions.
We evaluated the FoldPumpVac mask using the MTT method with L929 fibroblast cells, aligning with ISO 10993-5, the FDA-recognized consensus standard for in vitro cytotoxicity testing.
|
Method |
MTT method (L929 fibroblast cell line) |
|
Test sample |
Mask component (26.00 g) |
|
Extraction condition |
37°C for 24 h at 60 rpm |
|
Result |
Cell viability at 100% extract was 71.82% |
|
Acceptance threshold |
≥70% |
|
Conclusion |
No potential cytotoxicity under the stated test conditions |
What does that mean in plain terms?
The tested extract met the stated acceptance threshold. Under the reported laboratory conditions, the material did not demonstrate cytotoxic potential. That is the appropriate scope of the result.
2) Irritation: does the material trigger localized tissue reaction?
Irritation testing checks whether a material or its extracts produce localized adverse reactions such as redness or swelling upon contact.
We used ISO 10993-23, the FDA-recognized standard for assessing medical device irritation potential. Our third-party lab assessed both polar and non-polar extracts of the mask material.
|
Animal model |
New Zealand rabbit |
|
Scoring system |
Erythema (0–4) + edema (0–4) |
|
Result |
Final score for polar extract: 0.00 |
|
Result |
Final score for non-polar extract: 0.00 |
|
Acceptance criterion |
≤1.0 |
|
Conclusion |
Intracutaneous irritation requirements met under the stated test conditions |
A final score of 0.00 in both extract conditions means the laboratory did not observe an irritation response in this test. Under the stated conditions, the extracts met the acceptance criterion for irritation.
Sensitization testing evaluates whether a material may induce an allergic-type response after exposure.
We followed ISO 10993-10, the relevant standard for assessing skin sensitization. The third-party lab ran a maximization test after extracting the material under defined, prolonged conditions.
|
Method |
Maximization test |
|
Extraction conditions |
37°C for 72 h at 60 rpm |
|
Result |
Positive challenge incidence was 0% |
|
Conclusion |
The test item did not induce skin sensitization under the stated test conditions |
In this sensitization study, the tested material did not induce sensitization under the stated test conditions.
Suction performance is only half the job when we design a patient-contact mask.
The contact material also has to support controlled interface behavior. It needs to conform predictably, maintain a consistent seal, and hold up within a biological evaluation framework that makes sense for the intended use.
We spec silicone for the FoldPumpVac mask because a flexible contact material can conform to facial contours more predictably than a rigid interface. That flexibility matters for seal behavior during a panicked, time-sensitive rescue. Our biological evaluation results do not claim to answer every question about real-world use. What they do provide is a disciplined, lab-verified answer to a narrower question: whether the tested mask material cleared the relevant screens for cytotoxicity, irritation, and sensitization under the stated laboratory conditions.
71.82% cell viability in the cytotoxicity assessment, above the ≥70% threshold.
0.00 irritation scores for both polar and non-polar extracts.
0% positive incidence in the sensitization study.
Under the stated laboratory conditions, the FoldPumpVac mask material did not show cytotoxic potential, met the irritation acceptance criterion, and did not induce sensitization in the reported study. That is the kind of evidence we believe belongs in a serious product-safety conversation.
Comparison Graphic - Silicone vs Rigid Plastics
Don't compromise your child's airway with rigid, untested plastics. Choose the soft, flexible, and lab-verified safety of the FoldPumpVac. 👉 [Explore the Portable FoldPumpVac Series Here]
Biological evaluation results (cytotoxicity, irritation, and sensitization) are commonly used in technical files for medical‑device quality/regulatory dossiers
Q: What is biocompatibility testing for a choking rescue device?
A: It is a set of standardized biological evaluation methods used to assess how patient-contact materials behave under defined conditions. Depending on the contact scenario, the evaluation may include endpoints such as cytotoxicity, irritation, and sensitization within the ISO 10993 framework.
Q: What does MTT cytotoxicity measure?
A: It measures cell metabolic activity after exposure to material extracts. It serves as an in vitro screen for cytotoxic potential and is recognized by FDA under ISO 10993-5.
Q: Did Fitiger’s tested component pass the irritation and sensitization tests?
A: Yes. The third-party lab reported intracutaneous reactivity scores of 0.00 for both polar and non-polar extracts, and the sensitization study reported 0% positive incidence under the stated laboratory conditions.
Q: Does passing these tests guarantee zero risk for every person?
A: No. No biological evaluation can account for every possible individual variable. These results support the conclusion that the tested material met the stated acceptance criteria for cytotoxicity, irritation, and sensitization under the reported laboratory conditions.
Q: Does biological safety testing equal FDA marketing authorization?
A: No. Biological evaluation is one part of a larger quality and regulatory picture. FDA authorization depends on the device type, the regulatory pathway, and the full supporting evidence package.
Explore the FoldPumpVac line
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Test conditions and conclusions per third-party lab reports completed on 2025-07-31.
External references are listed here for editorial verification and technical context. They are intentionally kept out of the main article body.
FDA guidance on ISO 10993-1: Explains the risk-based biological evaluation framework used to support medical device submissions.
FDA recognized standard detail: ISO 10993-5 Supports the cytotoxicity discussion and the use of an in vitro cytotoxicity standard.
FDA recognized standard detail: ISO 10993-10 Supports the sensitization discussion and the use of a skin sensitization standard.
FDA recognized standard detail: ISO 10993-23 Supports the irritation discussion and the use of an irritation standard.
